K042520

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: KLS
Advisory panel: Clinical Toxicology
Date received: 2004-09-16
Decision date: 2004-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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