510(k) K062460— VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2006-08-23
Decision date: 2006-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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