VITROS Immunodiagnostic Products CEA Reagent Pack— 510(k) K231517

Substantially Equivalent

Ortho Clinical Diagnostics

FDA 510(k) clearance K231517 for VITROS Immunodiagnostic Products CEA Reagent Pack, Substantially Equivalent on 2023-08-23. Applicant: Ortho Clinical Diagnostics.

Clearance details

Applicant: Ortho Clinical Diagnostics
Product code: Code DHX
Advisory panel: Immunology
Date received: 2023-05-25
Decision date: 2023-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgend, GB

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