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 Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
K896335
Creative Laboratory Products, Inc.
Hematology · 38d
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 12, 1988
BINAX EQUATE GLYCOHEMOGLOBIN
K874749
Binax, Inc.
Hematology · 268d
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
Cleared May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698
Helena Laboratories
Hematology · 74d
Cleared Apr 05, 1988
GLYCO-PROBE GSP
K873428
Isolab, Inc.
Chemistry · 224d
Cleared Feb 17, 1988
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
K875354
Ulster Scientific, Inc.
Hematology · 48d
Cleared Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010
Roche Diagnostic Systems, Inc.
Chemistry · 813d
Cleared Sep 29, 1987
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852
Sandare Chemical Co., Inc.
Hematology · 71d
Cleared Jul 28, 1987
FOCUS-GHB
K871679
Awareness Technology, Inc.
Hematology · 90d
Cleared Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388
Bio-Rad
Hematology · 90d
Cleared Apr 28, 1987
GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT
K864643
Pacific Hemostasis
Hematology · 153d
Cleared Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371
Bio-Rad
Hematology · 84d
Cleared Aug 19, 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
K861697
Awareness Technology, Inc.
Hematology · 106d
Cleared Aug 08, 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556
Sandare Chemical Co., Inc.
Hematology · 36d
Cleared May 16, 1986
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
K860572
Pointe Scientific, Inc.,
Hematology · 91d
Cleared Jul 30, 1985
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636
Bio-Rad
Hematology · 102d
Cleared Oct 15, 1984
GLYCO-TEK AFFINITY COLUMN
K842689
Helena Laboratories
Hematology · 97d
Cleared Jan 24, 1984
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294
Emd Chemicals, Inc.
Hematology · 47d