K052819

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: DEM
Advisory panel: Immunology
Date received: 2005-10-04
Decision date: 2005-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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