510(k) K042521— VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2004-09-16
Decision date: 2004-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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