VITROS AFP— 510(k) K213626

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K213626 for VITROS AFP, Substantially Equivalent on 2022-06-15. Applicant: Ortho Clinical Diagnostics.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code LOJ
Advisory panel: Immunology
Date received: 2021-11-17
Decision date: 2022-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pencoed, GB

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