K072443

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: CJY
Advisory panel: Clinical Chemistry
Date received: 2007-08-30
Decision date: 2007-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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