BILIRUBIN ASSAY ON THE OMNI S ANALYZER— 510(k) K040174

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K040174 for BILIRUBIN ASSAY ON THE OMNI S ANALYZER, Substantially Equivalent on 2004-05-14. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code MQM
Advisory panel: Clinical Chemistry
Date received: 2004-01-26
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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