Cleared Special

C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN

K133330 · Roche Diagnostics · Chemistry
Nov 2013
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K133330 is an FDA 510(k) clearance for the C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 26, 2013, 25 days after receiving the submission on November 1, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K133330 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2013
Decision Date November 26, 2013
Days to Decision 25 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

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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