FDA 510(k) Applications for Medical Device Product Code "GKR"
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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 |