K062123

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: DIO
Advisory panel: Clinical Toxicology
Date received: 2006-07-25
Decision date: 2006-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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