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GKR — System, Hemoglobin, Automated Class II

FDA Device Classification

Classification Details

Product Code
GKR
Device Class
Class II
Regulation Number
864.5620
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201217hemocueHemoCue Hb 301 SystemAugust 4, 2020
K200909ekf-diagnosticHemo Control (optional Add Pack Hemo Control DM)June 12, 2020
K181751hemocueHemoCue Hb 801 SystemFebruary 1, 2019
K182298immunostics inchemochroma PLUS SystemNovember 16, 2018
K172173ekf-diagnosticDiaSpect Tm, DiaSpect Tm CuvettesApril 6, 2018
K163465immunostics inchemochroma PLUS SystemSeptember 8, 2017
K122553acon laboratoriesMISSION PLUS HB HEMOGLOBIN TESTING SYSTEMAugust 5, 2013
K121752mec dynamicsAVIE TOTAL HB TEST SYSTEMJanuary 7, 2013
K110393ekf-diagnosticEKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGMarch 4, 2011
K090093stanbio laboratorySTANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMJune 10, 2009
K081719stanbio laboratorySTANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMJuly 18, 2008
K061047hemocueHEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801June 8, 2006
K041234hemocueHEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEMJune 10, 2004
K032482stanbio laboratorySTANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMOctober 24, 2003
K031898ekf diagnosticEKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEMSeptember 24, 2003
K032203hemocueHEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704August 25, 2003
K023561international technidyneITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEMJanuary 31, 2003
K020710biotest medizintechnikBIOTEST HEMOGLOBIN MEASURING SYSTEMAugust 14, 2002
K020616bayer diagnosticsBAYER RAPIDPOINT 405 SYSTEMJuly 17, 2002
K961312hemocueHEMOCUE B-HEMOGLOBIN SYSTEMSeptember 24, 1996