K083680

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: CEM
Advisory panel: Clinical Chemistry
Date received: 2008-12-12
Decision date: 2009-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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