COBAS INTEGRA BILIRUBIN DIRECT GEN.2— 510(k) K123965

Name: FDA 510(k) clearance K123965
Creator: U.S. Food and Drug Administration
Published: 2013-02-28

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K123965 for COBAS INTEGRA BILIRUBIN DIRECT GEN.2, Substantially Equivalent on 2013-02-28. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2012-12-26
Decision date: 2013-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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