GKR · Class II · 21 CFR 864.5620

FDA Product Code GKR: System, Hemoglobin, Automated

Leading manufacturers include Ekf Diagnostic GmbH, Hemocue, Inc. and Stanbio Laboratory.

39
Total
39
Cleared
103d
Avg days
1977
Since
39 devices
25–39 of 39
Cleared Apr 28, 1987
CLEARVIEW CW-10
K870210
Clearview Instruments, Inc.
Hematology · 98d
Cleared Mar 19, 1987
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
K865055
Diversa Corp.
Hematology · 85d
Cleared Mar 29, 1985
LASER-GLOBIN POWDER
K850094
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-GLOBIN
K850096
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 23, 1984
HEMOGLOBIN REAGENT SET
K841057
Medical Specialties, Inc.
Hematology · 11d
Cleared Oct 28, 1983
HEMOCUE PHOTOMETER TECHNICAL MANUAL
K832020
Aktiebolaget Leo Diagnostics
Hematology · 135d
Cleared Jun 16, 1983
HEMOGLOBIN REAGENT
K831618
Omega Medical Diagnostics
Hematology · 28d
Cleared Aug 25, 1981
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127
King Diagnostics, Inc.
Hematology · 29d
Cleared Dec 30, 1980
HEMESPEC II
K803015
Helena Laboratories
Hematology · 32d
Cleared Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
K803016
Helena Laboratories
Hematology · 32d
Cleared Oct 23, 1980
HGB3 (1:251)
K802266
R&D Systems, Inc.
Hematology · 37d
Cleared Feb 08, 1979
FLUID, RHEMOX-HB LYSING
K790030
Sysmex Corp.
Hematology · 36d
Cleared Sep 14, 1978
HEMOGLOBINOMETER MODEL 720 B
K781361
Innovative Medical Systems, Inc.
Hematology · 38d
Cleared Jun 22, 1978
SYSING AND HEMOGLOBIN REAGENT
K780829
Harleco
Hematology · 34d
Cleared Oct 07, 1977
BLANKING SOLUTION HGB
K771789
J.T. Baker Chemical Co.
Hematology · 17d