Cleared Traditional

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160

K080607 · Roche Diagnostics Corp. · Chemistry
May 2008
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K080607 is an FDA 510(k) clearance for the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 12, 2008, 69 days after receiving the submission on March 4, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K080607 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2008
Decision Date May 12, 2008
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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