Cleared Traditional

SENTINEL PLASMAPROTEINS CAL 3X

K081533 · SENTINEL CH. SpA · Chemistry
Jun 2008
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K081533 is an FDA 510(k) clearance for the SENTINEL PLASMAPROTEINS CAL 3X, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on June 25, 2008, 23 days after receiving the submission on June 2, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K081533 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2008
Decision Date June 25, 2008
Days to Decision 23 days
Submission Type Traditional
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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