Quo-Test A1c System— 510(k) K180509

Substantially Equivalent

Ekf-Diagnostic GmbH

FDA 510(k) clearance K180509 for Quo-Test A1c System, Substantially Equivalent on 2019-02-16. Applicant: Ekf-Diagnostic GmbH. Device class: 2.

Clearance details

Applicant: Ekf-Diagnostic GmbH
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2018-02-27
Decision date: 2019-02-16
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Barleben, DE

Download summary PDF View on FDA.gov ↗

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