K041720

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: MRR
Advisory panel: Clinical Chemistry
Date received: 2004-06-24
Decision date: 2004-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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