K031924

Substantially Equivalent

VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1

Applicant: Ortho-Clinical Diagnostics
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2003-06-23
Decision date: 2003-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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