FDA Product Code LCP: Assay, Glycosylated Hemoglobin
Leading manufacturers include Helena Laboratories, Bio-Rad and Bio-Rad Laboratories, Inc..
249
Total
249
Cleared
146d
Avg days
1978
Since
249 devices
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
Beckman Coulter, Inc.
Hematology
119d
Cleared
Dec 19, 2000
VARIANT II TOTAL GHB
Bio-Rad
Hematology
61d
Cleared
Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Roche Diagnostics Corp.
Hematology
74d
Cleared
May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
Abbott Laboratories
Hematology
339d
Cleared
Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
Pointe Scientific, Inc.,
Chemistry
60d
Cleared
Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
Abbott Laboratories
Hematology
187d
Cleared
Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Roche Diagnostics Corp.
Chemistry
190d
Cleared
Dec 17, 1998
VARIANT II HEMOGLOBIN A1C PROGRAM
Bio-Rad
Hematology
17d
Cleared
May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
Boehringer Mannheim Corp.
Hematology
166d
Cleared
Nov 24, 1997
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
Beckman Instruments, Inc.
Hematology
59d
Cleared
Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
Tosoh Medics, Inc.
Hematology
100d
Cleared
Sep 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
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
Bayer Corp.
Hematology
219d
Cleared
Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
Roche Diagnostic Systems, Inc.
Hematology
266d
Cleared
Jul 11, 1995
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
Helena Laboratories
Chemistry
200d
Cleared
Jun 09, 1995
ABBOTT VISION GLYCATED HB, MODIFICATION
Abbott Laboratories
Hematology
526d
Cleared
May 05, 1995
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C
Heraeus Kulzer, Inc.
Chemistry
39d
Cleared
Apr 14, 1995
VARIANT TOTAL GHB PROGRAM
Bio-Rad
Hematology
375d
Cleared
Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
Boehringer Mannheim Corp.
Hematology
417d
Cleared
Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
Heraeus Kulzer, Inc.
Hematology
139d
Cleared
Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
Bio-Rad
Hematology
134d
Cleared
Nov 05, 1993
GLYCOHEMOGLOBIN
Teco Diagnostics
Hematology
241d
Cleared
Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
Bio-Rad
Hematology
91d
Cleared
Jan 12, 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
Beckman Instruments, Inc.
Hematology
98d