VITROS Immuodiagnostic Products CA 125 II Reagent Pack— 510(k) K221355

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K221355 for VITROS Immuodiagnostic Products CA 125 II Reagent Pack, Substantially Equivalent on 2022-12-12. Applicant: Ortho Clinical Diagnostics.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code LTK
Advisory panel: Immunology
Date received: 2022-05-10
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgend, GB

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