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
97–120 of 249
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 Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010
Roche Diagnostic Systems, Inc.
Chemistry · 813d
Cleared Jul 06, 1987
MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
K871388
Bio-Rad
Hematology · 90d
Cleared Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371
Bio-Rad
Hematology · 84d
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
Cleared Jan 18, 1984
AUTO AIC ANALYZER SYSTEM
K833772
Helena Laboratories
Chemistry · 83d
Cleared Nov 03, 1983
GLYCO-JE,E CPMTRP
K833356
Helena Laboratories
Hematology · 36d
Cleared Sep 29, 1983
A-GENT GLYCOSYLATED HEMOGLOBIN
K832775
Abbott Laboratories
Chemistry · 44d
Cleared Aug 24, 1983
TITAN GEL GLYCO-HEME SYSTEM
K832087
Helena Laboratories
Hematology · 57d
Cleared Jun 22, 1983
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
K831478
Bio-Rad
Chemistry · 44d
Cleared Jun 16, 1983
HEMOGLOBIN ALC BY COLUMN TEST
K830935
Bio-Rad
Hematology · 84d
Cleared Feb 01, 1983
GLYCO HB QUIK COLUMN PROCEDURE
K823869
Helena Laboratories
Hematology · 40d
Cleared Dec 03, 1982
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867
Isolab, Inc.
Chemistry · 67d
Cleared Nov 16, 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977
Bio-Rad
Hematology · 39d
Cleared Sep 16, 1981
ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S
K811567
Ortho Diagnostic Systems, Inc.
Hematology · 104d
Cleared Sep 09, 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242
Cordis Corp.
Hematology · 29d
Cleared Jul 15, 1981
BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST
K811710
Bio-Rad
Toxicology · 28d
Cleared May 08, 1981
LANCER GLYCOSYLATED HEMOGLOBIN
K810638
Sherwood Medical Co.
Hematology · 59d
Cleared May 08, 1981
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
K810714
Sherwood Medical Co.
Hematology · 52d
Cleared May 08, 1981
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL
K811000
Corning Medical & Scientific
Hematology · 25d