LCP · Class II · 21 CFR 864.7470

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
121–144 of 249
Cleared Jul 19, 1994
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
K940971
Heraeus Kulzer, Inc.
Hematology · 139d
Cleared Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613
Bio-Rad
Hematology · 134d
Cleared Nov 05, 1993
GLYCOHEMOGLOBIN
K931183
Teco Diagnostics
Hematology · 241d
Cleared Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469
Bio-Rad
Hematology · 91d
Cleared Jan 12, 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
K925204
Beckman Instruments, Inc.
Hematology · 98d
Cleared Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
K921831
Abbott Laboratories
Hematology · 166d
Cleared Aug 17, 1992
MODIFICATION COLUMNMATE
K920820
Helena Laboratories
Hematology · 186d
Cleared Aug 04, 1992
REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT
K920397
Medical Analysis Systems, Inc.
Chemistry · 187d
Cleared Jul 28, 1992
POINTE 750 GLYCOMETER
K920449
Pointe Scientific, Inc.,
Hematology · 177d
Cleared Jul 10, 1992
COLUMNMATE II
K921676
Helena Laboratories
Hematology · 93d
Cleared Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305
Helena Laboratories
Hematology · 89d
Cleared Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614
Boehringer Mannheim Corp.
Hematology · 111d
Cleared Oct 31, 1991
BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
K912748
Binax, Inc.
Hematology · 132d
Cleared Sep 23, 1991
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
K905709
Beckman Instruments, Inc.
Hematology · 276d
Cleared Sep 05, 1991
AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM
K911625
Heraeus Kulzer, Inc.
Hematology · 147d
Cleared Feb 07, 1991
ABBOTT VISION(TM) GLYCATED HB
K904027
Abbott Laboratories
Hematology · 161d
Cleared Jan 15, 1991
GLYC-AFFIN(TM)-GA
K905513
Isolab, Inc.
Chemistry · 36d
Cleared Dec 26, 1990
GLYC-AFFIN GP
K904814
Isolab, Inc.
Chemistry · 63d
Cleared Sep 11, 1990
OPTIMATE HEMOGLOBIN A1C
K896830
Heraeus Kulzer, Inc.
Hematology · 281d
Cleared Jul 24, 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
K902455
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jul 24, 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
K902457
Analytical Control Systems, Inc.
Hematology · 50d
Cleared Jun 15, 1990
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
K901414
Helena Laboratories
Hematology · 81d
Cleared Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718
Roche Diagnostic Systems, Inc.
Chemistry · 118d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
K896334
Creative Laboratory Products, Inc.
Hematology · 38d