Cleared Special

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

K060108 · Roche Diagnostics Corp. · Chemistry
Feb 2006
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K060108 is an FDA 510(k) clearance for the COBAS INTEGRA CHLORIDE ELCTRODE GEN.2, a Electrode, Ion-specific, Chloride (Class II — Special Controls, product code CGZ), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on February 16, 2006, 34 days after receiving the submission on January 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K060108 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2006
Decision Date February 16, 2006
Days to Decision 34 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGZ — Electrode, Ion-specific, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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