Cleared Abbreviated

SENTINEL CLIN CHEM CAL

K051452 · Sentinel Ch. Srl · Chemistry
Oct 2005
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K051452 is an FDA 510(k) clearance for the SENTINEL CLIN CHEM CAL, 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 October 25, 2005, 145 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 K051452 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date October 25, 2005
Days to Decision 145 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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