FDA Product Code LCP: Assay, Glycosylated Hemoglobin
Leading manufacturers include Helena Laboratories, Bio-Rad and Abbott Laboratories.
249
Total
249
Cleared
146d
Avg days
1978
Since
249 devices
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 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
Roche Diagnostic Systems, Inc.
Chemistry
149d
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
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
Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
Bio-Rad
Hematology
134d
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
Cleared
Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
Abbott Laboratories
Hematology
166d
Cleared
Aug 17, 1992
MODIFICATION COLUMNMATE
Helena Laboratories
Hematology
186d
Cleared
Jul 10, 1992
COLUMNMATE II
Helena Laboratories
Hematology
93d
Cleared
Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
Helena Laboratories
Hematology
89d
Cleared
Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
Boehringer Mannheim Corp.
Hematology
111d
Cleared
Sep 23, 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
Beckman Instruments, Inc.
Hematology
276d
Cleared
Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
Abbott Laboratories
Hematology
161d
Cleared
Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
Helena Laboratories
Hematology
81d
Cleared
Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
Roche Diagnostic Systems, Inc.
Chemistry
118d
Cleared
Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
Helena Laboratories
Hematology
54d
Cleared
Dec 27, 1988
LABILE LYSING REAGENT
Helena Laboratories
Hematology
75d
Cleared
Sep 30, 1988
REP GLYCO SYSTEM
Helena Laboratories
Hematology
150d
Cleared
Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
Bio-Rad
Hematology
77d