ADVIA Centaur EBV-VCA IgM— 510(k) K233606

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K233606 for ADVIA Centaur EBV-VCA IgM, Substantially Equivalent on 2024-08-07. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code LSE
Advisory panel: Microbiology
Date received: 2023-11-09
Decision date: 2024-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà DAmunt, Barcelona, ES

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