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510(k) K020710

BIOTEST HEMOGLOBIN MEASURING SYSTEM by Biotest Medizintechnik GmbH — Product Code GKR

K020710 is an FDA 510(k) premarket notification submitted by Biotest Medizintechnik GmbH for the device "BIOTEST HEMOGLOBIN MEASURING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 14, 2002. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
March 5, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
Review Panel
HE
Submission Type

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  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes (April 6, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (August 5, 2013)
  • K121752 — AVIE TOTAL HB TEST SYSTEM (January 7, 2013)
  • K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOG (March 4, 2011)
  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)

FDA data resources