LCP · Class II · 21 CFR 864.7470

FDA Product Code LCP: Assay, Glycosylated Hemoglobin

Leading manufacturers include Helena Laboratories, Bio-Rad and Abbott Laboratories.

249
Total
249
Cleared
146d
Avg days
1978
Since
249 devices
49–72 of 249
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 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 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 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 Nov 16, 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977
Bio-Rad
Hematology · 39d
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 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 Oct 17, 1979
A-GENT GLYCOSPEC
K791642
Abbott Laboratories
Hematology · 55d
Cleared Aug 22, 1979
GLUCOHEMOGLOBIN CONTROL
K791428
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 27d
Cleared Jun 28, 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
K791135
Helena Laboratories
Hematology · 10d
Cleared Apr 23, 1979
QUIK COLUMN METHODOLOGY
K790583
Helena Laboratories
Hematology · 27d