Cleared Special

SENTINEL CHOLINESTERASE LIQUID

K051444 · Sentinel Ch. Srl · Toxicology
Jun 2005
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K051444 is an FDA 510(k) clearance for the SENTINEL CHOLINESTERASE LIQUID, a Colorimetry, Cholinesterase (Class I — General Controls, product code DIH), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on June 20, 2005, 18 days after receiving the submission on June 2, 2005. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3240.

Submission Details

510(k) Number K051444 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date June 20, 2005
Days to Decision 18 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIH — Colorimetry, Cholinesterase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3240

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