FDA Product Code LCP: Assay, Glycosylated Hemoglobin

Cleared Nov 12, 1999

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

K992921

Primus Corp.

Hematology · 74d

Cleared Nov 01, 1999

ABBOTT ARCHITECT GLYCATED HEMOGLOBIN

K991483

Abbott Laboratories

Hematology · 187d

Cleared Sep 30, 1999

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

K990992

Roche Diagnostics Corp.

Chemistry · 190d

Cleared Jan 28, 1999

HEMOCHEK SAMPLE COLLECTION KIT

K984529

Osborn Laboratories, Inc.

Hematology · 38d

Cleared Dec 17, 1998

VARIANT II HEMOGLOBIN A1C PROGRAM

K984268

Bio-Rad

Hematology · 17d

Cleared Nov 30, 1998

ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT

K983172

Diabetes Technologies, Inc. (Dti)

Hematology · 81d

Cleared Nov 25, 1998

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

K983726

Genzyme Corp.

Chemistry · 34d

Cleared Nov 20, 1998

PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT

K983253

Medisense, Inc.

Hematology · 65d

Cleared Aug 13, 1998

GLYCACOR

K980888

Exocell, Inc.

Chemistry · 157d

Cleared Jun 15, 1998

AIC - CHEK (HBAIC-I)

K973365

Express-Med, Inc.

Hematology · 280d

Cleared May 13, 1998

ACCU-CHEK A1C HEMOGLOBIN TEST

K974491

Boehringer Mannheim Corp.

Hematology · 166d

Cleared Nov 24, 1997

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT

K973696

Beckman Instruments, Inc.

Hematology · 59d

Cleared Sep 25, 1997

A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER

K972265

Tosoh Medics, Inc.

Hematology · 100d

Cleared Sep 05, 1997

EZCHEK/HBA BLOOD COLLECTION KIT

K971919

Flexsite Diagnostics, Inc.

Hematology · 105d

Cleared Jun 13, 1997

LXN FRUCTOSAMINE TEST SYSTEM

K962597

Lxn Corp.

Chemistry · 346d

Cleared Apr 22, 1997

HYDRAGEL 15 HB A1C KIT

K963844

Morax

Hematology · 209d

Cleared Sep 27, 1996

ROCHE UNIMATE FRUCTOSAMINE REAGENT

K961674

Roche Diagnostic Systems, Inc.

Chemistry · 149d

Cleared Jun 13, 1996

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

K955087

Bayer Corp.

Hematology · 219d

Cleared Feb 09, 1996

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

K952337

Roche Diagnostic Systems, Inc.

Hematology · 266d

Cleared Jul 11, 1995

COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN

K946274

Helena Laboratories

Chemistry · 200d

Cleared Jun 09, 1995

ABBOTT VISION GLYCATED HB, MODIFICATION

K936285

Abbott Laboratories

Hematology · 526d

Cleared May 05, 1995

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C

K951361

Heraeus Kulzer, Inc.

Chemistry · 39d

Cleared Apr 14, 1995

VARIANT TOTAL GHB PROGRAM

K941616

Bio-Rad

Hematology · 375d

Cleared Oct 11, 1994

TINA-QUANT HEMOGLOBIN A1C

K934070

Boehringer Mannheim Corp.

Hematology · 417d