K041322

Substantially Equivalent

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: DHX
Advisory panel: Immunology
Date received: 2004-05-18
Decision date: 2004-06-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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