510(k) K042838— VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2004-10-14
Decision date: 2004-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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