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
145–168 of 249
Cleared Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
K934070
Boehringer Mannheim Corp.
Hematology · 417d
Cleared Sep 14, 1994
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
K942009
Primus Corp.
Hematology · 142d
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 Mar 22, 1994
GLYCATED HEMOGLOBIN CALIBRATORS
K936204
Primus Corp.
Hematology · 83d
Cleared Mar 15, 1994
GLYCATED HEMOGLOBIN CONTROLS
K940143
Primus Corp.
Hematology · 63d
Cleared Nov 05, 1993
GLYCOHEMOGLOBIN
K931183
Teco Diagnostics
Hematology · 241d
Cleared Sep 09, 1993
745 GLYCOMAT
K933287
Drew Scientific , Ltd.
Hematology · 65d
Cleared Aug 19, 1993
PROTEIN-BOUND GLUCOSE ASSAYN KIT
K930823
Diagnostic Specialties
Hematology · 183d
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 21, 1992
GLYCOMAT HAEMOGLOBIN ANALYSER
K920198
Drew Scientific , Ltd.
Hematology · 188d
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