Calibrator, Multi-Analyte Mixture

FDA product code JIX · 298 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1150
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-12-30 – 2016-05-20

JIX 1988-01-05

PARAMAX URINE/CSF CALIBRATOR

Applicant Baxter Healthcare Corp

K number K874587

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JIX 1988-01-05

REAGENT A AND REAGENT B

Applicant Seradyn, Inc.

K number K874413

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JIX 1987-11-23

PROTEIN STANDARD CALIBRATOR

Applicant Wako Chemicals USA, Inc.

K number K871755

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JIX 1987-09-02

BIOTROL REFERENCE

Applicant Biotrol, USA, Inc.

K number K873118

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JIX 1987-09-02

MULTI ANALYTE MIXTURES, CALIBRATORS

Applicant Biotrol, USA, Inc.

K number K873116

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JIX 1987-09-02

PARAMAX URINE/CSF CALIBRATOR

Applicant American Dade

K number K872789

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JIX 1987-05-28

FLAME PHOTOMETER STANDARD #60083 160 NA/8K

Applicant In Vitro Diagnostics, Inc.

K number K871184

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JIX 1987-05-28

FLAME PHOTOMETER STANDARD #60082 140 NA/5K

Applicant In Vitro Diagnostics, Inc.

K number K871183

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JIX 1987-05-28

FLAME PHOTOMETER STANDARD #60081 120 NA/2K

Applicant In Vitro Diagnostics, Inc.

K number K871182

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JIX 1987-05-21

QM300 CALIBRATOR A PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K871341

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JIX 1987-05-12

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95

Applicant Em Diagnostic Systems, Inc.

K number K871638

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JIX 1987-05-08

IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR

Applicant Instrumentation Laboratory CO

K number K871664

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JIX 1987-02-13

DU PONT LIQUID MULTI-ANALYTE CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K864909

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JIX 1986-10-21

SOLUTION B- NA 50MEQ/L, K 40 MEQ/L

Applicant Reagent Laboratory, Inc.

K number K863502

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JIX 1986-09-29

PARAMAX ELECTROLYTE CALIBRATOR

Applicant American Dade

K number K863489

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JIX 1986-09-26

ACE II (TRI-LEVEL)

Applicant Medical Analysis Systems, Inc.

K number K863095

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JIX 1986-08-19

SERACON(TM) CAL (PRODUCT NO. DO35)

Applicant Bhp Diagnostix, Inc.

K number K862594

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JIX 1986-08-04

EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95

Applicant Em Diagnostic Systems, Inc.

K number K862703

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JIX 1986-07-29

DU PONT DRUG CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K861786

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JIX 1986-04-07

EMDS CHEMISTRY CALIBRATORS, LEVELS I & II

Applicant Em Diagnostic Systems, Inc.

K number K860765

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JIX 1986-03-14

QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A

Applicant Kallestad Laboratories, Inc.

K number K855014

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JIX 1986-02-19

PARAMAX COMPREHENSIVE CALIBRATOR

Applicant American Dade

K number K855199

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JIX 1985-10-25

DMA CALIBRATORS

Applicant Data Medical Associates, Inc.

K number K854092

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JIX 1985-06-25

INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU

Applicant Alpkem Corp.

K number K851990

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JIX 1985-06-14

CORNING CERTAIN -ISE

Applicant Corning Medical & Scientific

K number K851939

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JIX 1985-05-20

FISHER DIAGNOSTICS KDA CALIBRATOR II

Applicant Fisher Scientific Co., LLC

K number K851151

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JIX 1985-05-20

FISHER DIAGNOSTICS KDA CALIBRATOR I

Applicant Fisher Scientific Co., LLC

K number K851150

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JIX 1985-05-10

COBAS CALIBRATOR SERUM

Applicant Roche Diagnostic Systems, Inc.

K number K850859

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JIX 1985-04-01

CALIBRATOR B 88133

Applicant Hi Chem, Inc.

K number K850405

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JIX 1985-02-27

ROCHE STANDARDS FOR CHLORIDE & CO2

Applicant Roche Diagnostic Systems, Inc.

K number K850396

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JIX 1985-01-08

CRITIC-ARS

Applicant Dimension Diagnostics

K number K844709

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JIX 1985-01-03

GEMCAL ENI REFERENCE SERUM

Applicant Biocell Laboratories, Inc.

K number K844344

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JIX 1984-12-11

REFERRIL CALIBRATORS

Applicant Instrumentation Laboratory CO

K number K844585

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JIX 1984-11-27

SERACON TM SR III

Applicant Bhp Diagnostix, Inc.

K number K844027

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JIX 1984-11-27

SERACON TM SR IV

Applicant Bhp Diagnostix, Inc.

K number K844026

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JIX 1984-10-17

DOUMENT TM LINEARITY TEST STANDARDS

Applicant Casco Standards

K number K843947

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JIX 1984-06-22

CHANGES IN THE CHEMICAL COMP. OF 5

Applicant Nova Biomedical Corp.

K number K841464

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JIX 1984-05-21

VENTREXYME EIA CONTROLS IMMUNOASSAY

Applicant Vxr, Inc.

K number K841456

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JIX 1984-05-11

SODIUM & POTASSIUM STANDARD SOL 80

Applicant Reagent Laboratory, Inc.

K number K841420

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JIX 1984-05-11

SODIUM & POTASSIUM STANDARD SOLUT

Applicant Reagent Laboratory, Inc.

K number K841419

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JIX 1984-03-23

HDL CHOLESTEROL CONTROLS-LEVELS

Applicant Preventive Diagnostics Corp.

K number K840278

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JIX 1984-03-23

TRIGLYCERIDE/CHOLESTEROL AQUEOUS

Applicant Preventive Diagnostics Corp.

K number K840219

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JIX 1983-11-14

PARAMAX BILIRUBIN CALIBRATORS

Applicant American Dade

K number K833005

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JIX 1983-10-04

LYPHOCHEK SERUM REF. STANDARD-BOVINE

Applicant Bio-Rad

K number K832695

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JIX 1983-08-11

SERALYZER MULTICOMPONENT CALIBRATORS

Applicant Miles Laboratories, Inc.

K number K832046

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JIX 1983-05-09

COBAS STANDARDS FOR GLUCOSE & BUN

Applicant Roche Diagnostic Systems, Inc.

K number K831030

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JIX 1983-03-10

SALT BRIDGE SOLUTION & URINE DILUENT

Applicant Shaban Mfg. Co.

K number K830341

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JIX 1982-12-09

KM-KAL L3

Applicant Kmn Products, Inc.

K number K823044

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JIX 1982-11-05

KM-KAL L5

Applicant Kmn Products, Inc.

K number K823046

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JIX 1982-11-05

KM-KAL L4

Applicant Kmn Products, Inc.

K number K823045

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JIX 1982-11-05

KM-KAL L2

Applicant Kmn Products, Inc.

K number K823043

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JIX 1982-11-05

KM-KAL L1

Applicant Kmn Products, Inc.

K number K823042

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JIX 1982-11-05

GLUCOSE/UREA NITROGEN STANDARD

Applicant Emd Chemicals, Inc.

K number K822937

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JIX 1982-08-24

CO2/CI STANDARDS

Applicant Gilford Diagnostics

K number K822289

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JIX 1982-07-13

REF. ELECTRODE SOL'N.;STANDARD B

Applicant Avl Scientific Corp.

K number K821885

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JIX 1982-07-02

NOVA V FLUIDS PACK & EXTERNAL STANDARDS

Applicant Shaban Mfg. Co.

K number K821794

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JIX 1982-06-14

NOVA IV FLUIDS PACK & EXTERNAL STANDARDS

Applicant Shaban Mfg. Co.

K number K821623

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JIX 1982-05-03

NOVA II FLUIDS PACK

Applicant Shaban Mfg. Co.

K number K821030

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JIX 1982-04-26

NOVA III FLUIDS PACK

Applicant Shaban Mfg. Co.

K number K820947

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JIX 1982-04-01

NOVA I FLUIDS PACK

Applicant Shaban Mfg. Co.

K number K820701

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JIX 1982-04-01

EXTERNAL STANDARDS-SODIUMNPOTASSIUM

Applicant Shaban Mfg. Co.

K number K820700

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JIX 1982-01-22

SODIUM & POTASSIUM PRODUCTS

Applicant Alko Diagnostic Corp.

K number K813127

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JIX 1981-12-18

DOCUMENT LINEARITY TEST STANDARDS

Applicant North American Standards

K number K813411

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JIX 1981-10-19

BECKMAN ICS CALIBRATOR

Applicant Beckman Instruments, Inc.

K number K812649

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JIX 1981-07-23

HITACHI 705 CALIBRATOR

Applicant Boehringer Mannheim Corp.

K number K811921

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JIX 1981-04-17

BIO SET TM PHOSPHOROUS CALIBRATOR

Applicant Boehringer Mannheim Corp.

K number K810964

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JIX 1981-01-09

FLAME PHOTOMETRY REAGENTS

Applicant Laboratory Products, Inc.

K number K803051

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JIX 1980-12-11

COMBINED GLUCOSE AND BUN STANDARDS

Applicant Mallinckrodt Critical Care

K number K802825

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JIX 1980-12-11

COMBUNED CALCIUM AND PHOSPHORUS STD.

Applicant Mallinckrodt Critical Care

K number K802824

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JIX 1980-12-11

BUN/GLUCOSE STANDARDS

Applicant Gilford Diagnostics

K number K802633

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JIX 1980-12-11

ALBUMIN/TOTAL PROTEIN STANDARDS

Applicant Gilford Diagnostics

K number K802632

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JIX 1980-12-10

CENTRIFICHEM COMB. SERUM-BASED CALIB.

Applicant Union Carbide Corp.

K number K802741

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JIX 1980-06-26

REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER

Applicant Simmler, Inc.

K number K801222

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JIX 1980-04-29

GAL-PUT CONTROLS, NORMAL&DEFICIENT

Applicant Sigma Chemical Co.

K number K800910

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JIX 1980-01-21

CESIUM DILUENT (1.5 MM/L)

Applicant Gilford Diagnostics

K number K800043

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JIX 1980-01-21

SODIUM/POTASSIUM 140/5 MEQ/L)

Applicant Gilford Diagnostics

K number K800041

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JIX 1980-01-21

SODIUM/POTASSIUM (100/100 MEQ/E)

Applicant Gilford Diagnostics

K number K800040

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JIX 1979-12-31

SERACON-SRII

Applicant Bhp Diagnostix, Inc.

K number K792487

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JIX 1979-12-31

SERACON-SRI (PROD. # D029

Applicant Bhp Diagnostix, Inc.

K number K792486

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JIX 1979-12-31

SERACON-SRI

Applicant Bhp Diagnostix, Inc.

K number K792485

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JIX 1979-12-06

PRINCIPAL ANALYTE REFERENCE SERUM

Applicant Beckman Instruments, Inc.

K number K792384

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JIX 1979-11-13

LANCER L-INA HUMAN REFERENCE SERUM

Applicant Sherwood Medical Industries

K number K792013

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JIX 1979-10-17

CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD

Applicant Gilford Diagnostics

K number K791874

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JIX 1979-10-11

SERACON CAL D025

Applicant Bhp Diagnostix, Inc.

K number K791956

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JIX 1979-09-17

CALIBRATOR II

Applicant Hi Chem, Inc.

K number K791694

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JIX 1979-09-17

CALIBRATOR I

Applicant Hi Chem, Inc.

K number K791693

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JIX 1979-02-26

SERACON-N

Applicant Bhp Diagnostix, Inc.

K number K782039

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JIX 1979-02-08

SERACON-A

Applicant Bhp Diagnostix, Inc.

K number K782037

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JIX 1978-12-04

SERACON-SRII

Applicant Bhp Diagnostix, Inc.

K number K781758

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JIX 1978-12-04

SERACON-SRI

Applicant Bhp Diagnostix, Inc.

K number K781757

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JIX 1978-11-15

CALIBRATOR, BOVINE SERUM

Applicant Bio-Reagents & Diagnostics, Inc.

K number K781702

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JIX 1978-05-19

COMP. CLIN. CHEM. REF. SERUM-BENCHMARK

Applicant Beckman Instruments, Inc.

K number K780553

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JIX 1977-04-18

Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K770012

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JIX 1977-04-18

Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K770011

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JIX 1977-04-18

Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K770010

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JIX 1977-04-15

BLOOD GAS ANALYZER-CALIBRATION GAS

Applicant Gardner Cryogenics

K number K770494

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JIX 1977-02-11

SMA REFERENCE SERUM 3

Applicant Technicon Instruments Corp.

K number K770142

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JIX 1976-12-30

OB-GYN CONTROL SERA (CODE 196300)

Applicant Amersham Corp.

K number K761309

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