GKR

Product Code: GKR


Products Classified as GKR

2316System, Hemoglobin, AutomatedAutomated Hemoglobin System.

Total Product Life Cycle (TPLC) Devices

2316System, Hemoglobin, AutomatedAutomated Hemoglobin System.

FDA Consensus Standards

System, Hemoglobin, Automated [25011]21 CFR §864.5620 🔎

Pre-market Notifications for GKR

K201217HemoCue Hb 301 SystemHemoCue AB
K200909Hemo Control (optional Add Pack Hemo Control DM)EKF-diagnostic GmbH
K182298Hemochroma PLUS SystemImmunostics, Inc.
K181751HemoCue Hb 801 SystemHemoCue AB
K172173DiaSpect Tm, DiaSpect Tm CuvettesEKF-diagnostic GmbH
K163465Hemochroma PLUS SystemIMMUNOSTICS, INC.
K122553MISSION PLUS HB HEMOGLOBIN TESTING SYSTEMACON LABORATORIES, INC.
K121752AVIE TOTAL HB TEST SYSTEMMEC DYNAMICS CORP
BK110036Automated Hemoglobin SystemDiaspect Medical GMBH
K110393EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE WEKF-DIAGNOSTIC GMBH
K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMSTANBIO LABORATORY
K081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMSTANBIO LABORATORY
BK060048Automated Hemoglobin SystemHemoCue AB
K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801HEMOCUE AB
K041234HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMHEMOCUE, INC.

Global Unique Device Identification Database

10385480355367SYSTEM, HEMOGLOBIN, AUTOMATED
00304040103975SYSTEM, HEMOGLOBIN, AUTOMATED
00304040103814SYSTEM, HEMOGLOBIN, AUTOMATED
00304040103777SYSTEM, HEMOGLOBIN, AUTOMATED
00630414947549SYSTEM, HEMOGLOBIN, AUTOMATED
00630414947532SYSTEM, HEMOGLOBIN, AUTOMATED
00630414947525SYSTEM, HEMOGLOBIN, AUTOMATED
00630414570471SYSTEM, HEMOGLOBIN, AUTOMATED
00630414553610SYSTEM, HEMOGLOBIN, AUTOMATED
00630414553603SYSTEM, HEMOGLOBIN, AUTOMATED
00630414492650SYSTEM, HEMOGLOBIN, AUTOMATED
00630414492629SYSTEM, HEMOGLOBIN, AUTOMATED
00630414477855SYSTEM, HEMOGLOBIN, AUTOMATED
00630414477848SYSTEM, HEMOGLOBIN, AUTOMATED
00630414477831SYSTEM, HEMOGLOBIN, AUTOMATED

Maude Adverse Events

STAT PROFILE PRIME PLUS ANALYZER SYSTEMNOVA BIOMEDICAL CORP2020-01-30
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-10-01
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-06-25
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-03-21
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-03-21
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-01-10
HEMOCUE HB 201 DM SYSTEMHEMOCUE AB2019-01-10
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-01-09
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-01-02
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2019-01-02
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-05-24
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-05-17
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-05-16
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-05-16
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-05-16
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-04-05
RAPIDPOINT 405 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-03-20
RAPIDLAB 1265 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-03-05
RAPIDLAB 1265 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-03-05
I-STAT EG6+ CARTRIDGEABBOTT POINT OF CARE2018-03-05
COBAS B 123 <4> SYSTEMROCHE DIAGNOSTICS2018-02-02
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2018-01-17
I-STAT CHEM8+ CARTRIDGEABBOTT POINT OF CARE2017-12-15
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2017-10-06
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2017-07-13
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2017-07-10
RAPIDPOINT 500 BLOOD GAS ANALYZERSIEMENS HEALTHCARE DIAGNOSTICS2017-06-21
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2016-09-15
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-06-07
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-06-07
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-05-24
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-05-04
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-05-02
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2016-04-04
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-03-15
RAPIDPOINT 500SIEMENS HEALTHCARE DIAGNOSTICS2016-03-11
HEMOCUE HB 201+ SYSTEMHEMOCUE AB2015-12-21
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-11-05
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-10-28
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-09-16
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-08-04
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-07-14
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-07-13
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-06-11
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-05-22
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-05-20
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-04-27
RAPIDPOINT 405SIEMENS HEALTHCARE DIAGNOSTICS2015-04-23
OPTI CCA-TS2OPTI MEDICAL SYSTEMS INC.2015-04-09
HEMOCUE HB201+ SYSTEMHEMOCUE AB2015-03-13
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