K043384

Substantially Equivalent

VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: LDO
Advisory panel: Clinical Toxicology
Date received: 2004-12-09
Decision date: 2005-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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