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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 2024-11-22

Nova Allegro HbA1c Assay, Nova Allegro Analyzer

Applicant Nova Biomedical Corporation

K number K221326

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LCP 2023-12-06

Q-Pad Test System

Applicant Qurasense

K number K231465

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LCP 2023-09-27

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

Applicant Abbott Diagnostics Technologies AS

K number K214117

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LCP 2020-03-26

Aina HbA1c Monitoring System 2

Applicant Jana Care, Inc.

K number K192987

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LCP 2019-10-29

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

Applicant Ixensor Co, Ltd.

K number K192369

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LCP 2019-08-15

OneDraw A1C Test System

Applicant Drawbridge Health, Inc.

K number K183230

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LCP 2019-04-12

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

Applicant Ixensor Co, Ltd.

K number K181915

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LCP 2019-02-16

Quo-Test A1c System

Applicant Ekf-Diagnostic GmbH

K number K180509

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LCP 2018-09-25

skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

Applicant Skyla Corporation H.S.P.B

K number K173127

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LCP 2018-02-27

ACE Hemoglobin A1c (HbA1c) Reagent

Applicant Alfa Wassermann Diagnostic Technologies, LLC

K number K170623

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LCP 2017-11-21

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

Applicant Abbott Rapid Diagnostics

K number K171650

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LCP 2017-10-12

Lucica Glycated Albumin-L

Applicant Asahi Kasei Pharma Corporation

K number K170147

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LCP 2017-07-28

cobas HbA1c Test, cobas b 101 system

Applicant Roche Diagnostics Operations

K number K163633

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LCP 2017-06-16

A1C EZ Glycohemoglobin Analysis System

Applicant Biohermes Co., Ltd.

K number K161533

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LCP 2017-02-17

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

Applicant Sebia

K number K162281

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LCP 2016-11-21

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set

Applicant Diazyme Laboratories

K number K160762

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LCP 2016-01-29

URight Hemoglobin A1c system, FORA A1c System

Applicant Taidoc Technology Corporation

K number K142664

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LCP 2013-05-09

VARIANT(TM) II TURBO HBA1C KIT - 2.0

Applicant Bio-Rad Laboratories, Inc., Clinical Systems Divis

K number K130990

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LCP 2013-04-25

VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

Applicant Bio-Rad Laboratories, Inc., Clinical Systems Divis

K number K130860

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LCP 2012-12-12

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

Applicant Axis-Shield Diagnostics, Ltd.

K number K121842

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LCP 2012-12-06

CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C

Applicant Sebia

K number K122101

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LCP 2012-10-26

VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

Applicant Bio-Rad Laboratories, Inc., Clinical Systems Divis

K number K122472

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LCP 2012-10-12

GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY

Applicant Beckman Coulter, Inc.

K number K120199

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LCP 2012-09-13

LABONACHECK A1C

Applicant Ceragem International, Inc.

K number K111128

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LCP 2012-09-11

UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT

Applicant Beckman Coulter, Inc.

K number K121492

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LCP 2012-09-07

HEMOCUE HBA1C 501

Applicant Infopia Co, Ltd.

K number K121366

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LCP 2012-08-06

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K113437

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LCP 2012-05-14

EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL

Applicant Medica Corp.

K number K120497

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LCP 2011-12-23

TINA-QUANT HBA1C GEN.2

Applicant Roche Diagnostics

K number K110313

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LCP 2011-11-22

PREMIER HB9210 HBA1C ANALYZER

Applicant Primus Corporation Dba Trinity Biotech

K number K112015

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LCP 2011-08-25

ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY

Applicant Siemens Healthcare Diagnostics

K number K110934

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LCP 2011-07-20

AVIE A1C TEST SYSTEM

Applicant Mec Dynamics Corp

K number K093548

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LCP 2011-05-19

ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL

Applicant Seppim S.A.S.

K number K100547

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LCP 2011-05-17

DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT

Applicant Diazyme Laboratories

K number K110188

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LCP 2011-05-13

DIMENSIONS HB1C KIT, MODEL DF105A

Applicant Siemens Healthcare Diagnostics

K number K102510

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LCP 2011-02-15

AFINION ANALYZER

Applicant Axis-Shield Poc AS

K number K110056

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LCP 2011-02-14

DIMENSION VISA HBA1C, MODEL K3105A

Applicant Siemens Heatlhcare Diagnostics, Inc.

K number K102045

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LCP 2011-01-20

TQ HBA1C GEN3

Applicant Roche

K number K102914

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LCP 2010-08-27

ST AIA PACK HBA1C

Applicant Tosoh Bioscience, Inc.

K number K100304

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LCP 2010-01-14

CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023

Applicant Infopia Co, Ltd.

K number K082275

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LCP 2009-12-11

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K091711

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LCP 2009-07-27

VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730

Applicant Bio-Rad Laboratories, Inc.

K number K090699

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LCP 2009-06-11

MODIFICATION TO AVIE A1C TEST SYSTEM

Applicant Mec Dynamics Corp

K number K091400

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LCP 2009-05-14

A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

Applicant Bayer Healthcare, LLC

K number K090413

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LCP 2009-03-20

AVIE A1C TEST SYSTEM

Applicant Mec Dynamics Corp

K number K081269

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LCP 2009-01-08

ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS

Applicant Siemens Medical Solutions Diagnostics

K number K081895

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LCP 2008-10-17

ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT

Applicant Horiba Abx

K number K073309

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LCP 2008-09-16

G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8

Applicant Tosoh Bioscience, Inc.

K number K071132

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LCP 2008-05-23

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

Applicant Jas Diagnostics, Inc.

K number K080618

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LCP 2008-04-18

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

Applicant Roche Diagnostics Corp.

K number K072714

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LCP 2008-03-17

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

Applicant Axis-Shield Diagnostics, Ltd.

K number K072686

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LCP 2007-11-26

PRIMUS A1CARE ASSAY

Applicant Primus Corp.

K number K062658

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LCP 2007-10-09

DCA VANTAGE, MODEL 5075

Applicant Siemens Medical Solutions Diagnostics

K number K071466

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LCP 2007-06-25

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

Applicant Bio-Rad Laboratories Inc., Clinical Systems Divisi

K number K070819

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LCP 2007-05-07

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

Applicant Bio-Rad Laboratories, Inc.

K number K070452

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LCP 2007-04-17

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

Applicant Alfa Wassermann, Inc.

K number K063306

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LCP 2007-04-09

MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

Applicant Diazyme Laboratories

K number K070734

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LCP 2007-03-21

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

Applicant Thermo Electron OY

K number K063209

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LCP 2006-12-27

MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM

Applicant Bio-Rad Laboratories Inc., Clinical Systems Divisi

K number K063643

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LCP 2006-12-01

VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

Applicant Bio-Rad Laboratories, Inc.

K number K063400

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LCP 2006-04-06

VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

Applicant Ortho-Clinical Diagnostics, Inc.

K number K060650

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LCP 2006-02-03

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

Applicant Microgenics Corp.

K number K053411

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LCP 2006-01-20

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

Applicant Bio-Rad Laboratories, Inc.

K number K060001

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LCP 2005-09-30

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

Applicant Roche Diagnostics Corp.

K number K052464

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LCP 2005-08-08

HEMOGLOBIN A1C REAGENT SET

Applicant Teco Diagnostics

K number K051200

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LCP 2005-07-22

AFINION HBALC

Applicant Axis-Shield Poc AS

K number K050574

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LCP 2005-06-28

HBA1C ENZYMATIC ASSAY

Applicant General Atomics

K number K050178

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LCP 2005-06-13

INVIEW

Applicant Metrika, Inc.

K number K051321

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LCP 2004-11-17

SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT

Applicant Beckman Coulter, Inc.

K number K042459

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LCP 2004-10-29

DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT

Applicant Diazyme Laboratories

K number K042193

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LCP 2004-10-15

LIQUI-HEME GLYCO A1C ASSAY

Applicant Biodiagnostic Intl

K number K031296

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LCP 2004-09-09

THE VITROS 5,1 FS CHEMISTRY SYSTEM

Applicant Ortho-Clinical Diagnostics

K number K041764

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LCP 2004-08-16

G5 I HBA1C TEST, G5 II HBA1C TEST

Applicant Provalis Diagnostics , Ltd.

K number K041635

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LCP 2004-06-09

BIO-RAD D-10 DUAL PROGRAM

Applicant Bio-Rad Laboratories, Inc.

K number K041444

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LCP 2004-04-15

VARIANT II HEMOGLOBIN A1C

Applicant Bio-Rad Laboratories, Inc.

K number K040872

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LCP 2004-02-09

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

Applicant Seradyn, Inc.

K number K033674

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LCP 2003-12-23

A1CNOW FOR HOME AND PROFESSIONAL USE

Applicant Metrika, Inc.

K number K033847

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LCP 2003-11-14

OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)

Applicant Olympus America, Inc.

K number K031380

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LCP 2003-11-03

ATAC HEMOGLOBIN A1C REAGENT KIT

Applicant Clinical Data, Inc.

K number K031042

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LCP 2003-09-02

ARKIT HBA1C

Applicant Arkray, Inc.

K number K030553

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LCP 2003-08-27

D-10 HEMOGLOBIN A1C

Applicant Bio-Rad Laboratories, Inc.

K number K031043

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LCP 2003-08-06

HEMOGLOBIN A1C REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K031539

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LCP 2003-05-02

GLYCA-DIRECT FRUCTOSAMINE

Applicant Polymedco, Inc.

K number K023654

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LCP 2003-01-13

RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS

Applicant Randox Laboratories, Ltd.

K number K023763

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LCP 2002-12-13

A1CNOW FOR HOME USE

Applicant Metrika, Inc.

K number K022661

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LCP 2002-11-26

RANDOX HAEMOGLOBIN A1C

Applicant Randox Laboratories, Ltd.

K number K021897

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LCP 2002-06-14

HEMOGLOBIN A1C CONTROL

Applicant Canterbury Scientific , Ltd.

K number K021484

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LCP 2002-04-24

POLYMEDCO HBA1C TEST

Applicant Polymedco, Inc.

K number K020532

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LCP 2002-02-15

A1CNOW FOR PROFESSIONAL USE

Applicant Metrika, Inc.

K number K020235

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LCP 2002-02-15

A1CNOW FOR RX HOME USE

Applicant Metrika, Inc.

K number K020234

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LCP 2002-01-22

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

Applicant Diabetes Technologies, Inc.

K number K013465

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LCP 2001-11-15

DIMENSION HAIC ASSAY, MODEL DF105

Applicant Dade Behring, Inc.

K number K011852

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LCP 2001-11-02

GLYCOSAL II HBA 1C TEST

Applicant Provalis Diagnostics , Ltd.

K number K011933

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LCP 2001-10-26

INFINITY HBA KIT, MODELS 537-A, 537-B

Applicant Sigma Diagnostics, Inc.

K number K012410

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LCP 2001-10-04

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

Applicant Thermo Dma, Inc.

K number K012525

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LCP 2001-09-18

G7 AUTOMATED HPLC ANALYZER

Applicant Tosoh Medics, Inc.

K number K011434

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LCP 2001-07-10

SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT

Applicant Beckman Coulter, Inc.

K number K010748

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LCP 2000-12-19

VARIANT II TOTAL GHB

Applicant Bio-Rad

K number K003280

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LCP 2000-12-18

MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C

Applicant Roche Diagnostics Corp.

K number K003120

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LCP 2000-09-26

DRX HBA1C - FOR PRESCRIPTION HOME USE

Applicant Metrika, Inc.

K number K000885

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