Cleared Traditional

COBAS C 111 ANALYZER

K071211 · Roche Diagnostics · Chemistry
Jul 2007
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K071211 is an FDA 510(k) clearance for the COBAS C 111 ANALYZER, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on July 30, 2007, 90 days after receiving the submission on May 1, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K071211 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2007
Decision Date July 30, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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