K063143

Substantially Equivalent

VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LFX
Advisory panel: Microbiology
Date received: 2006-10-16
Decision date: 2006-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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