Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

FDA product code KPO · 121 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5820
Review panel: GU
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1978-04-05 – 2026-08-19

KPO 2026-08-19

Nipro Dry Acid Concentrate Mixer

Applicant Nipro Technical Solutions, Incoporated

K number K260799

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KPO 2026-01-29

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K253462

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KPO 2025-09-09

Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K252180

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KPO 2025-04-04

Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K243786

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KPO 2024-07-12

HemoCare Bicarbonate Concentrate Set (BCS)

Applicant Deka Research and Development

K number K240920

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KPO 2024-05-10

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K233950

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KPO 2024-01-18

NxStage PureFlow Solution

Applicant Nxstage Medical, Inc.

K number K233213

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KPO 2023-12-01

pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K233159

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KPO 2023-08-04

Citric Complete Liquid Citric Acid Concentrate

Applicant Nipro Renal Solutions USA, Corp.

K number K223431

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KPO 2023-03-03

NIKKICART

Applicant Renal Care Dialysis Solutions, S.A. DE C.V.

K number K221652

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KPO 2022-08-12

Hemo-Lyte C Cartridge

Applicant Di-Chem, Inc.

K number K202508

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KPO 2022-05-12

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K212620

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KPO 2021-07-23

HMB32 Dialysis Solution

Applicant Haemopharm Biofluids S.R.L.

K number K212052

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KPO 2020-11-25

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

Applicant Nipro Renal Solutions USA, Corp.

K number K193155

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KPO 2020-05-08

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K192209

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KPO 2020-04-24

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K192017

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KPO 2020-02-24

NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K191474

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KPO 2020-01-22

Isopure Dry Acid Dissolution System

Applicant Isopure, Corp.

K number K191093

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KPO 2018-12-07

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)

Applicant Global Scientific Technologies, LLC

K number K180679

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KPO 2018-03-06

Citric Complete Dry Citric Acid (45X)

Applicant Dimesol USA, LLC

K number K171750

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KPO 2017-10-13

Citryte

Applicant Di-Chem, Inc.

K number K171015

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KPO 2017-05-18

bibag

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K number K162716

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KPO 2017-01-06

PrismaSATE

Applicant Baxter Healthcare Corporation

K number K162887

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KPO 2016-10-20

Rockwell Medical CitraPure Acid Concetrate

Applicant Rockwell Medical

K number K160847

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KPO 2013-08-29

FRESENIUS DRY ACID DISSOLUTION UNITS

Applicant Fresenius Medical Care North America

K number K131611

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KPO 2012-05-25

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

Applicant Gambro Renal Products

K number K120333

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KPO 2012-03-29

ACDS

Applicant Isopure, Corp.

K number K120005

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KPO 2011-04-25

SOLCART B

Applicant B. Braun Avitum AG

K number K102194

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KPO 2009-08-07

ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A

Applicant Baxter Healthcare Corp

K number K090002

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KPO 2008-02-04

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

Applicant Gambro Renal Products

K number K072908

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KPO 2008-01-29

SOLCART B

Applicant B. Braun Medizintechnologie GmbH

K number K072760

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KPO 2007-06-15

FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

Applicant Fresenius Medical Care North America

K number K071387

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KPO 2007-03-29

FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

Applicant Fresenius Medical Care North America

K number K070177

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KPO 2006-11-17

ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE

Applicant Rockwell Medical Technologies, Inc.

K number K062399

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KPO 2005-12-22

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

Applicant Nxstage Medical, Inc.

K number K053286

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KPO 2005-11-09

B. BRAUN MODIFIED BICARBONATE DIALYSATE

Applicant B.Braun Medical, Inc.

K number K052393

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KPO 2005-11-02

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

Applicant Gambro Renal Products

K number K052253

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KPO 2005-08-22

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)

Applicant Dialysis Solutions, Inc.

K number K050827

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KPO 2004-08-27

NXSTAGE PUREFLOW-B SOLUTION

Applicant Nxstage Medical, Inc.

K number K042045

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KPO 2004-08-27

B. BRAUN BICARBONATE DIALYSATE

Applicant B.Braun Medical, Inc.

K number K041683

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KPO 2004-08-27

ACCUSOL DIALYSIS SOLUTION

Applicant Baxter Healthcare Corp

K number K041428

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KPO 2004-03-03

B.BRAUN PREMIXED DIALYSATE

Applicant B.Braun Medical, Inc.

K number K034066

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KPO 2003-11-26

NXSTAGE PUREFLOW SOLUTION

Applicant Nxstage Medical, Inc.

K number K033386

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KPO 2003-05-20

FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES

Applicant Fresenius Medical Care

K number K030497

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KPO 2003-02-28

ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE

Applicant Rockwell Medical Technologies, Inc.

K number K023985

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KPO 2003-01-03

BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON

Applicant Rockwell Medical Technologies, Inc.

K number K022521

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KPO 2002-12-23

DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE

Applicant Rockwell Medical Technologies, Inc.

K number K022500

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KPO 2002-10-21

NXSTAGE PREMIXED DIALYSATE

Applicant Nxstage Medical, Inc.

K number K022913

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KPO 2002-10-21

DIASOL-ADDITIVES

Applicant Diasol, Inc.

K number K020231

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KPO 2002-04-23

DIASOL-BICARB

Applicant Diasol, Inc.

K number K020230

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KPO 2002-02-04

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

Applicant Nxstage Medical, Inc.

K number K013655

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KPO 2002-01-18

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

Applicant Di-Chem, Inc.

K number K012547

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KPO 2002-01-18

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER

Applicant Di-Chem, Inc.

K number K012328

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KPO 2002-01-15

PRISMASATE

Applicant Gambro Renal Products

K number K013448

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KPO 2002-01-08

BICART

Applicant Gambro Renal Products

K number K013724

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KPO 2001-08-02

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

Applicant Gambro Renal Products

K number K011368

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KPO 2001-06-11

ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS

Applicant Advanced Renal Technologies, Inc.

K number K010760

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KPO 2000-06-30

NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

Applicant Novex Pharma

K number K001059

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KPO 2000-06-08

CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX

Applicant Advanced Renal Technologies, Inc.

K number K000792

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KPO 1999-10-22

DRYASOL ACID CONCENTRATE MIX

Applicant Diasol, Inc.

K number K993212

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KPO 1999-08-05

DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE

Applicant Rockwell Medical Technologies, Inc.

K number K983618

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KPO 1999-05-07

ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER

Applicant Althin Biopharm, Inc.

K number K990507

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KPO 1999-04-15

ALTHIN MEDICAL AB ALTRACART II

Applicant Althin Medical AB

K number K990010

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KPO 1998-11-06

NATURALYTE, MODEL # 08-4004-1

Applicant Kaybath, Inc.

K number K982813

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KPO 1998-08-26

HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE

Applicant Solution Technologies

K number K982378

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KPO 1998-06-16

ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES

Applicant International Medical Products, Inc.

K number K981003

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KPO 1998-06-11

DRYALYSATE CONCENTRATE

Applicant Advanced Renal Technologies, Inc.

K number K980659

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KPO 1998-05-26

DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL

Applicant Solution Technologies

K number K981043

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KPO 1997-10-30

ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE

Applicant International Medical Products, Inc.

K number K973253

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KPO 1997-06-16

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS

Applicant International Medical Products, Inc.

K number K971053

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KPO 1996-03-01

ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS

Applicant Rockwell Medical Supply

K number K954527

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KPO 1994-10-17

FRESENIUS DIALYSATE ACID CONCENTRATE

Applicant Fresenius USA, Inc.

K number K922088

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KPO 1994-09-30

WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE

Applicant Western Dialysis Supplies , Ltd.

K number K941958

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KPO 1994-09-12

HEMODIALYSIS BATH

Applicant Medi-Tech, Inc.

K number K922990

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KPO 1994-03-30

GRANULYTE DIALYSATE CONCENTRATE

Applicant Fresenius USA, Inc.

K number K922005

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KPO 1994-03-22

GAMBRO BICART 720G

Applicant C.G.H. Medical, Inc.

K number K940601

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KPO 1991-07-17

GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING

Applicant Fresenius USA, Inc.

K number K911459

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KPO 1991-07-05

ACETATE-FREE DIALYSLATE SOLUTION

Applicant Physio, Inc.

K number K903835

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KPO 1991-04-24

ACID CONCENTRATE SOLUTIONS

Applicant Biopharm, Inc.

K number K910319

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KPO 1991-04-18

PREMIXED DIALYSATE FOR HEMODIAFILTRATION

Applicant Baxter Healthcare Corp

K number K910270

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KPO 1991-04-09

HAEMODIALYSIS CONCENTRATE

Applicant Bdh, Inc.

K number K904946

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KPO 1991-03-15

ACETATE CONCENTRATES FOR HEMODIALYSIS

Applicant Medical Components, Inc.

K number K905021

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KPO 1990-07-27

GC-01 THROUGH GC-99 ACETATE CONCENTRATE

Applicant Granite Chemical Co., Inc.

K number K901473

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KPO 1990-07-27

GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS

Applicant Granite Chemical Co., Inc.

K number K901472

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KPO 1990-07-27

GC-1000 THROUGH GC-3005 ACID CONCENTRATE

Applicant Granite Chemical Co., Inc.

K number K901471

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KPO 1990-01-11

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

Applicant P & A Co.

K number K893991

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KPO 1989-12-27

FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB

Applicant Fresenius USA, Inc.

K number K896111

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KPO 1989-12-13

BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE

Applicant Baxter Healthcare Corp

K number K895199

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KPO 1989-04-17

BICARBONATE CONCENTRATE POWDER

Applicant Haemolyte, Inc.

K number K891921

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KPO 1989-04-07

SODIUM BICARBONATE, U.S.P.

Applicant Williams Medical Co.

K number K891159

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KPO 1989-01-30

BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS

Applicant Baxter Healthcare Corp

K number K884725

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KPO 1988-12-22

HEMODIALYSIS CONCENTRATES

Applicant Dove Medical Supplies

K number K883068

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KPO 1988-05-26

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS

Applicant Baxter Healthcare Corp

K number K880102

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KPO 1987-10-05

HOSPAL DIALYSATE FOR C.A.V.H.D.

Applicant Delmed, Inc.

K number K872857

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KPO 1987-06-03

HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS

Applicant Inventory Supply Corp.

K number K870979

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KPO 1987-03-27

POWDERED BICARBONATE CONCENTRATE

Applicant Bicarbolyte Corp.

K number K865078

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KPO 1987-03-17

HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI

Applicant Dial Medical of Florida, Inc.

K number K864265

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KPO 1987-03-10

BICARBONATE MIXING SYSTEM

Applicant Morris Tool , Ltd.

K number K864942

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KPO 1986-10-16

SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS

Applicant American Healthcare Corp.

K number K863631

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KPO 1986-09-23

HOSPAL DIALYSATE FOR CAVHD

Applicant Hospal Medical Corp.

K number K861156

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