K042643

Substantially Equivalent

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: DCF
Advisory panel: Immunology
Date received: 2004-09-27
Decision date: 2004-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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