Cleared Abbreviated

SENTINEL PLASMAPROTEINS CAL 3X

K051457 · Sentinel Ch. Srl · Chemistry
Jul 2005
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K051457 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. Srl (Milano, IT). The FDA issued a Cleared decision on July 25, 2005, 53 days after receiving the submission on June 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K051457 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date July 25, 2005
Days to Decision 53 days
Submission Type Abbreviated
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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