FDA 510(k) Applications for Medical Device Product Code "GKR"
(System, Hemoglobin, Automated)

FDA 510(k) Number Applicant Device Name Decision Date
K122553 ACON LABORATORIES, INC. MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM 08/05/2013
K020616 BAYER DIAGNOSTICS CORP. BAYER RAPIDPOINT 405 SYSTEM 07/17/2002
K020710 BIOTEST MEDIZINTECHNIK GMBH BIOTEST HEMOGLOBIN MEASURING SYSTEM 08/14/2002
K031898 EKF DIAGNOSTIC GMBH EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM 09/24/2003
K172173 EKF-diagnostic GmbH DiaSpect Tm, DiaSpect Tm Cuvettes 04/06/2018
K110393 EKF-DIAGNOSTIC GMBH EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W 03/04/2011
K200909 EKF-diagnostic GmbH Hemo Control (optional Add Pack Hemo Control DM) 06/12/2020
K061047 HEMOCUE AB HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 06/08/2006
K201217 HemoCue AB HemoCue Hb 301 System 08/04/2020
K181751 HemoCue AB HemoCue Hb 801 System 02/01/2019
K961312 HEMOCUE, INC. HEMOCUE B-HEMOGLOBIN SYSTEM 09/24/1996
K032203 HEMOCUE, INC. HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 08/25/2003
K041234 HEMOCUE, INC. HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM 06/10/2004
K163465 IMMUNOSTICS, INC. hemochroma PLUS System 09/08/2017
K182298 Immunostics, Inc. hemochroma PLUS System 11/16/2018
K023561 INTERNATIONAL TECHNIDYNE CORP. ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM 01/31/2003
K121752 MEC DYNAMICS CORP AVIE TOTAL HB TEST SYSTEM 01/07/2013
K090093 STANBIO LABORATORY STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM 06/10/2009
K032482 STANBIO LABORATORY STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM 10/24/2003
K081719 STANBIO LABORATORY STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM 07/18/2008


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