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
193–216 of 249
Cleared Nov 13, 1979
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777
Corning Medical & Scientific
Chemistry · 64d
Cleared Oct 17, 1979
A-GENT GLYCOSPEC
K791642
Abbott Laboratories
Hematology · 55d
Cleared Sep 27, 1979
FAST FLOW #60310
K791365
Hi Chem, Inc.
Hematology · 64d
Cleared Aug 22, 1979
GLUCOHEMOGLOBIN CONTROL
K791428
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 27d
Cleared Jun 28, 1979
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT
K791103
Leeco Diagnostics, Inc.
Hematology · 15d
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
Cleared Jan 26, 1979
G-HB QUIK COLUMN CONTROL
K790046
Helena Laboratories
Hematology · 21d
Cleared Dec 20, 1978
COLUMN TEST, HEMOGLOBIN A
K781948
Bio-Rad
Hematology · 29d
Cleared Nov 07, 1978
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
K780573
Bd Becton Dickinson Vacutainer Systems Preanalytic
Hematology · 211d
Cleared Nov 07, 1978
HEMOGLOBIN, TESTING SYSTEM
K781851
Isolab, Inc.
Hematology · 4d