K983690

Substantially Equivalent

VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: MOI
Advisory panel: Immunology
Date received: 1998-10-21
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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