510(k) K063164— VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code LDJ
Advisory panel: Clinical Toxicology
Date received: 2006-10-18
Decision date: 2006-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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