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Assay, Glycosylated Hemoglobin

FDA product code LCP · 238 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7470
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-11-07 – 2024-11-22

LCP 2000-08-21

GLYCOSAL HBA1C TEST

Applicant Provalis Diagnostics , Ltd.

K number K001392

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LCP 2000-07-26

DRX HBA1C

Applicant Metrika, Inc.

K number K000887

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LCP 2000-05-25

ABBOTT IMX GLYCATED HEMOGLOBIN II

Applicant Abbott Laboratories

K number K992085

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LCP 2000-05-22

NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY

Applicant Primus, Inc.

K number K993131

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LCP 2000-03-21

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

Applicant Genzyme Corp.

K number K000239

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LCP 1999-12-21

PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

Applicant Primus Corp.

K number K994045

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LCP 1999-12-21

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET

Applicant Pointe Scientific, Inc.,

K number K993590

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LCP 1999-12-21

HEMOCHEK-A1C SAMPLE COLLECTION KIT

Applicant Osborn Group, Inc.

K number K990899

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LCP 1999-12-16

FRUCTOSAMINE, MODEL FR 106-01

Applicant A.P. Total Care, Inc.

K number K991246

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LCP 1999-11-26

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

Applicant Biosafe Laboratories, Inc.

K number K991850

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LCP 1999-11-12

PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II

Applicant Primus Corp.

K number K992921

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LCP 1999-11-01

ABBOTT ARCHITECT GLYCATED HEMOGLOBIN

Applicant Abbott Laboratories

K number K991483

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LCP 1999-09-30

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

Applicant Roche Diagnostics Corp.

K number K990992

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LCP 1999-01-28

HEMOCHEK SAMPLE COLLECTION KIT

Applicant Osborn Laboratories, Inc.

K number K984529

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LCP 1998-12-17

VARIANT II HEMOGLOBIN A1C PROGRAM

Applicant Bio-Rad

K number K984268

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LCP 1998-11-30

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

Applicant Diabetes Technologies, Inc. (Dti)

K number K983172

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LCP 1998-11-25

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

Applicant Genzyme Corp.

K number K983726

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LCP 1998-11-20

PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT

Applicant Medisense, Inc.

K number K983253

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LCP 1998-08-13

GLYCACOR

Applicant Exocell, Inc.

K number K980888

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LCP 1998-06-15

AIC - CHEK (HBAIC-I)

Applicant Express-Med, Inc.

K number K973365

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LCP 1998-05-13

ACCU-CHEK A1C HEMOGLOBIN TEST

Applicant Boehringer Mannheim Corp.

K number K974491

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LCP 1997-11-24

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT

Applicant Beckman Instruments, Inc.

K number K973696

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LCP 1997-09-25

A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER

Applicant Tosoh Medics, Inc.

K number K972265

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LCP 1997-09-05

EZCHEK/HBA BLOOD COLLECTION KIT

Applicant Flexsite Diagnostics, Inc.

K number K971919

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LCP 1997-06-13

LXN FRUCTOSAMINE TEST SYSTEM

Applicant Lxn Corp.

K number K962597

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LCP 1997-04-22

HYDRAGEL 15 HB A1C KIT

Applicant Morax

K number K963844

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LCP 1996-09-27

ROCHE UNIMATE FRUCTOSAMINE REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K961674

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LCP 1996-06-13

HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

Applicant Bayer Corp.

K number K955087

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LCP 1996-02-09

ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P

Applicant Roche Diagnostic Systems, Inc.

K number K952337

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LCP 1995-07-11

COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN

Applicant Helena Laboratories

K number K946274

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LCP 1995-06-09

ABBOTT VISION GLYCATED HB, MODIFICATION

Applicant Abbott Laboratories

K number K936285

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LCP 1995-05-05

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C

Applicant Heraeus Kulzer, Inc.

K number K951361

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LCP 1995-04-14

VARIANT TOTAL GHB PROGRAM

Applicant Bio-Rad

K number K941616

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LCP 1994-10-11

TINA-QUANT HEMOGLOBIN A1C

Applicant Boehringer Mannheim Corp.

K number K934070

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LCP 1994-09-14

PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY

Applicant Primus Corp.

K number K942009

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LCP 1994-07-19

AMES DCA 2000 HEMOGLOBIN ALC CONTROLS

Applicant Heraeus Kulzer, Inc.

K number K940971

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LCP 1994-04-05

RADIAS MONOCLONAL HBA 1C ASSAY

Applicant Bio-Rad

K number K935613

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LCP 1994-03-22

GLYCATED HEMOGLOBIN CALIBRATORS

Applicant Primus Corp.

K number K936204

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LCP 1994-03-15

GLYCATED HEMOGLOBIN CONTROLS

Applicant Primus Corp.

K number K940143

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LCP 1993-11-05

GLYCOHEMOGLOBIN

Applicant Teco Diagnostics

K number K931183

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LCP 1993-09-09

745 GLYCOMAT

Applicant Drew Scientific , Ltd.

K number K933287

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LCP 1993-08-19

PROTEIN-BOUND GLUCOSE ASSAYN KIT

Applicant Diagnostic Specialties

K number K930823

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LCP 1993-03-29

VARIANT(TM) HEMOGLOBIN A 1C PROGRAM

Applicant Bio-Rad

K number K926469

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LCP 1993-01-12

BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED

Applicant Beckman Instruments, Inc.

K number K925204

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LCP 1992-09-29

IMX(R) GLYCATED HEMOGLOBIN

Applicant Abbott Laboratories

K number K921831

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LCP 1992-08-17

MODIFICATION COLUMNMATE

Applicant Helena Laboratories

K number K920820

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LCP 1992-08-04

REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT

Applicant Medical Analysis Systems, Inc.

K number K920397

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LCP 1992-07-28

POINTE 750 GLYCOMETER

Applicant Pointe Scientific, Inc.,

K number K920449

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LCP 1992-07-21

GLYCOMAT HAEMOGLOBIN ANALYSER

Applicant Drew Scientific , Ltd.

K number K920198

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LCP 1992-07-10

COLUMNMATE II

Applicant Helena Laboratories

K number K921676

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LCP 1992-06-09

GLYCO-TEK AFFINITY COLUMN KIT

Applicant Helena Laboratories

K number K921305

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LCP 1991-12-02

FRUCTOSAMINE ABG21 TEST SYSTEM

Applicant Boehringer Mannheim Corp.

K number K913614

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LCP 1991-10-31

BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT

Applicant Binax, Inc.

K number K912748

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LCP 1991-09-23

BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT

Applicant Beckman Instruments, Inc.

K number K905709

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LCP 1991-09-05

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM

Applicant Heraeus Kulzer, Inc.

K number K911625

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LCP 1991-02-07

ABBOTT VISION(TM) GLYCATED HB

Applicant Abbott Laboratories

K number K904027

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LCP 1991-01-15

GLYC-AFFIN(TM)-GA

Applicant Isolab, Inc.

K number K905513

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LCP 1990-12-26

GLYC-AFFIN GP

Applicant Isolab, Inc.

K number K904814

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LCP 1990-09-11

OPTIMATE HEMOGLOBIN A1C

Applicant Heraeus Kulzer, Inc.

K number K896830

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LCP 1990-07-24

ABNORMAL GLYCOHEMOGLOBIN CONTROL

Applicant Analytical Control Systems, Inc.

K number K902457

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LCP 1990-07-24

ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)

Applicant Analytical Control Systems, Inc.

K number K902455

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LCP 1990-06-28

DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)

Applicant Primus, Inc.

K number K896582

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LCP 1990-06-15

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581

Applicant Helena Laboratories

K number K901414

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LCP 1990-06-12

ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY

Applicant Roche Diagnostic Systems, Inc.

K number K900718

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LCP 1989-12-11

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR

Applicant Creative Laboratory Products, Inc.

K number K896335

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LCP 1989-12-11

CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER

Applicant Creative Laboratory Products, Inc.

K number K896334

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LCP 1989-12-07

GLYCOTEST II GLYHB ASSAY KIT

Applicant Pierce Chemical Co.

K number K895661

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LCP 1989-10-23

GLYCABEN

Applicant Exocell, Inc.

K number K893453

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LCP 1989-06-20

REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207

Applicant Helena Laboratories

K number K893224

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LCP 1989-06-16

PRIMUS MODEL CLC 330

Applicant Primus, Inc.

K number K891235

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LCP 1989-03-28

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE

Applicant Sigma Diagnostics, Inc.

K number K884184

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LCP 1988-12-27

LABILE LYSING REAGENT

Applicant Helena Laboratories

K number K884315

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LCP 1988-11-22

GHB SAMPLE PAPER

Applicant Isolab, Inc.

K number K880673

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LCP 1988-09-30

REP GLYCO SYSTEM

Applicant Helena Laboratories

K number K881863

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LCP 1988-08-12

BINAX EQUATE GLYCOHEMOGLOBIN

Applicant Binax, Inc.

K number K874749

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LCP 1988-08-01

DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY

Applicant Bio-Rad

K number K882222

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LCP 1988-08-01

BIO-RAD HEMOGLOBIN DETECTOR

Applicant Bio-Rad

K number K882051

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LCP 1988-05-06

TITAN GEL-PC GLYCO-HEME(TM) SYSTEM

Applicant Helena Laboratories

K number K880698

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LCP 1988-04-05

GLYCO-PROBE GSP

Applicant Isolab, Inc.

K number K873428

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LCP 1988-02-17

UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM

Applicant Ulster Scientific, Inc.

K number K875354

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LCP 1987-12-22

FRUCTOSAMINE TEST (ROCHE)

Applicant Roche Diagnostic Systems, Inc.

K number K854010

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LCP 1987-09-29

EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST

Applicant Sandare Chemical Co., Inc.

K number K872852

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LCP 1987-07-28

FOCUS-GHB

Applicant Awareness Technology, Inc.

K number K871679

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LCP 1987-07-06

MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER

Applicant Bio-Rad

K number K871388

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LCP 1987-04-28

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT

Applicant Pacific Hemostasis

K number K864643

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LCP 1986-09-16

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)

Applicant Bio-Rad

K number K862371

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LCP 1986-08-19

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)

Applicant Awareness Technology, Inc.

K number K861697

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LCP 1986-08-08

SANDARE GLYCOHEMOGLOBIN PROCEDURE

Applicant Sandare Chemical Co., Inc.

K number K862556

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LCP 1986-05-16

GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K860572

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LCP 1985-08-19

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN

Applicant Clinical Technology Corp.

K number K852986

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LCP 1985-07-30

DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM

Applicant Bio-Rad

K number K851636

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LCP 1985-07-05

GLYCO-CHECK

Applicant Thyroid Diagnostics, Inc.

K number K852111

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LCP 1984-10-15

GLYCO-TEK AFFINITY COLUMN

Applicant Helena Laboratories

K number K842689

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LCP 1984-01-24

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB

Applicant Emd Chemicals, Inc.

K number K834294

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LCP 1984-01-18

AUTO AIC ANALYZER SYSTEM

Applicant Helena Laboratories

K number K833772

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LCP 1984-01-03

GLYCOGLOBIN KIT

Applicant Endocrine Sciences Products

K number K833805

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LCP 1983-11-03

GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL

Applicant Helena Laboratories

K number K833356

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LCP 1983-09-29

A-GENT GLYCOSYLATED HEMOGLOBIN

Applicant Abbott Laboratories

K number K832775

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LCP 1983-08-24

TITAN GEL GLYCO-HEME SYSTEM

Applicant Helena Laboratories

K number K832087

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LCP 1983-08-01

CLINOVATIVE II DIAGNOSTIC KIT

Applicant Pierce Chemical Co.

K number K831837

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