COBAS INTEGRA C 111— 510(k) K063744

Substantially Equivalent

Rochdiag

FDA 510(k) clearance K063744 for COBAS INTEGRA C 111, Substantially Equivalent on 2007-01-17. Applicant: Rochdiag. Device class: 2.

Clearance details

Applicant: Rochdiag
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2006-12-18
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.