Hemo Control (optional Add Pack Hemo Control DM)— 510(k) K200909

Name: FDA 510(k) clearance K200909
Creator: U.S. Food and Drug Administration
Published: 2020-06-12

Substantially Equivalent

Ekf-Diagnostic GmbH

FDA 510(k) clearance K200909 for Hemo Control (optional Add Pack Hemo Control DM), Substantially Equivalent on 2020-06-12. Applicant: Ekf-Diagnostic GmbH. Device class: 2.

Clearance details

Applicant: Ekf-Diagnostic GmbH
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2020-04-06
Decision date: 2020-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Barleben, DE

Download summary PDF View on FDA.gov ↗

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