BIOTEST HEMOGLOBIN MEASURING SYSTEM— 510(k) K020710

Name: FDA 510(k) clearance K020710
Creator: U.S. Food and Drug Administration
Published: 2002-08-14

Substantially Equivalent

Biotest Medizintechnik GmbH

FDA 510(k) clearance K020710 for BIOTEST HEMOGLOBIN MEASURING SYSTEM, Substantially Equivalent on 2002-08-14. Applicant: Biotest Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Biotest Medizintechnik GmbH
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2002-03-05
Decision date: 2002-08-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

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