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
169–192 of 249
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
GLYCOHEMOGLOBIN
K810958
Macomb Chemical Co.
Toxicology · 161d
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
Cleared Jan 16, 1981
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K802832
Sandare Chemical Co., Inc.
Hematology · 65d
Cleared Dec 11, 1980
GLYCOHEMOGLOBIN IN WHOLE BLOOD
K802721
Sigma Chemical Co.
Hematology · 41d
Cleared Oct 10, 1980
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN
K802233
Helena Laboratories
Hematology · 25d
Cleared Sep 26, 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857
Helena Laboratories
Hematology · 164d
Cleared Aug 12, 1980
GLYCOSYLATED HEMOGLOBIN KIT
K801561
Amersham Corp.
Hematology · 35d
Cleared Jul 08, 1980
SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.
K801422
Sandare Chemical Co., Inc.
Hematology · 21d
Cleared Jun 30, 1980
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
K801289
Leeco Diagnostics, Inc.
Hematology · 31d
Cleared Apr 29, 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
K800794
Isolab, Inc.
Chemistry · 20d