K062637

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: DJR
Advisory panel: Clinical Toxicology
Date received: 2006-09-05
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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