VITROS CHEMISTRY PRODUCTS DTIBC REAGENT— 510(k) K052867

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K052867 for VITROS CHEMISTRY PRODUCTS DTIBC REAGENT, Substantially Equivalent on 2005-12-23. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JMO
Advisory panel: Clinical Chemistry
Date received: 2005-10-11
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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