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

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 Sep 08, 2017
hemochroma PLUS System
K163465
Immunostics Inc.,
Hematology · 270d
Cleared Aug 05, 2013
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553
ACON Laboratories, Inc.
Hematology · 349d
Cleared Jan 07, 2013
AVIE TOTAL HB TEST SYSTEM
K121752
Mec Dynamics Corp
Hematology · 207d
Cleared Mar 04, 2011
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K110393
Ekf Diagnostic GmbH
Hematology · 21d
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 Jun 08, 2006
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
K061047
Hemocue AB
Hematology · 55d
Cleared Jun 10, 2004
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234
Hemocue, Inc.
Hematology · 31d
Cleared Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482
Stanbio Laboratory
Hematology · 73d
Cleared Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K031898
Ekf Diagnostic GmbH
Hematology · 97d
Cleared Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203
Hemocue, Inc.
Hematology · 38d
Cleared Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561
International Technidyne Corp.
Hematology · 100d
Cleared Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710
Biotest Medizintechnik GmbH
Hematology · 162d
Cleared Jul 17, 2002
BAYER RAPIDPOINT 405 SYSTEM
K020616
Bayer Diagnostics Corp.
Hematology · 142d
Cleared Sep 24, 1996
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312
Hemocue, Inc.
Hematology · 173d
Cleared Oct 20, 1995
IL682, CO-OXIMETER
K945677
Instrumentation Laboratory CO
Hematology · 336d
Cleared Oct 05, 1995
AVL OMNI ANALYZER
K954018
Avl Scientific Corp.
Hematology · 41d
Cleared Jul 11, 1991
HEMOGLOBIN REAGENT
K910745
Toa Medical Electronics USA, Inc.
Hematology · 140d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353
Ciba Corning Diagnostics Corp.
Chemistry · 141d

About Product Code GKR - Regulatory Context