GKR · Class II · 21 CFR 864.5620

FDA Product Code GKR: System, Hemoglobin, Automated

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

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 Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553
ACON Laboratories, Inc.
Hematology · 349d
Cleared Jun 10, 2009
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
K090093
Stanbio Laboratory
Hematology · 147d
Cleared Jul 18, 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719
Stanbio Laboratory
Hematology · 30d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482
Stanbio Laboratory
Hematology · 73d
Cleared Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561
International Technidyne Corp.
Hematology · 100d
Cleared Oct 20, 1995
IL682, CO-OXIMETER
K945677
Instrumentation Laboratory CO
Hematology · 336d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353
Ciba Corning Diagnostics Corp.
Chemistry · 141d
Cleared Mar 23, 1984
HEMOGLOBIN REAGENT SET
K841057
Medical Specialties, Inc.
Hematology · 11d
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 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

About Product Code GKR - Regulatory Context