GKR · Class II · 21 CFR 864.5620

FDA Product Code GKR: System, Hemoglobin, Automated

Leading manufacturers include Stanbio Laboratory, Ekf Diagnostic GmbH and Helena Laboratories.

39
Total
39
Cleared
103d
Avg days
1977
Since
39 devices
25–39 of 39
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