510(k) K160495— VITROS® Automation Solutions

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code KLI
Advisory panel: Clinical Chemistry
Date received: 2016-02-22
Decision date: 2016-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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