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
73–96 of 249
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 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 Jun 20, 1989
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207
K893224
Helena Laboratories
Hematology · 54d
Cleared Mar 28, 1989
SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE
K884184
Sigma Diagnostics, Inc.
Chemistry · 175d
Cleared Dec 27, 1988
LABILE LYSING REAGENT
K884315
Helena Laboratories
Hematology · 75d
Cleared Nov 22, 1988
GHB SAMPLE PAPER
K880673
Isolab, Inc.
Hematology · 277d
Cleared Sep 30, 1988
REP GLYCO SYSTEM
K881863
Helena Laboratories
Hematology · 150d
Cleared Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051
Bio-Rad
Hematology · 77d
Cleared Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222
Bio-Rad
Hematology · 67d