K983875

Substantially Equivalent

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LTK
Advisory panel: Immunology
Date received: 1998-11-02
Decision date: 1999-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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