GKR · Class II · 21 CFR 864.5620

FDA Product Code GKR: System, Hemoglobin, Automated

Leading manufacturers include Ekf Diagnostic GmbH, Hemocue AB and Helena Laboratories.

39
Total
39
Cleared
103d
Avg days
1977
Since

FDA 510(k) Cleared System, Hemoglobin, Automated Devices (Product Code GKR)

39 devices
1–24 of 39
Cleared Aug 04, 2020
HemoCue Hb 301 System
K201217
Hemocue AB
Hematology · 90d
Cleared Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909
Ekf Diagnostic GmbH
Hematology · 67d
Cleared Feb 01, 2019
HemoCue Hb 801 System
K181751
Hemocue AB
Hematology · 214d
Cleared Nov 16, 2018
hemochroma PLUS System
K182298
Immunostics Inc.,
Hematology · 84d
Cleared Apr 06, 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173
Ekf Diagnostic GmbH
Hematology · 261d
Cleared Oct 20, 1995
IL682, CO-OXIMETER
K945677
Instrumentation Laboratory CO
Hematology · 336d
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

About Product Code GKR - Regulatory Context