COBAS C BILIRUBIN TOTAL GEN.3— 510(k) K131544

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K131544 for COBAS C BILIRUBIN TOTAL GEN.3, Substantially Equivalent on 2013-07-17. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 2013-05-29
Decision date: 2013-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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