K060650

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LCP
Advisory panel: Hematology
Date received: 2006-03-13
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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