AXINON® LDL-p Test System— 510(k) K210801

Substantially Equivalent

Numares AG

FDA 510(k) clearance K210801 for AXINON® LDL-p Test System, Substantially Equivalent on 2023-07-19. Applicant: Numares AG.

Clearance details

Applicant: Numares AG
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 2021-03-17
Decision date: 2023-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Regensburg, DE

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