Cleared Traditional

SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

K051114 · Sentinel Ch. Srl · Chemistry
Nov 2005
Decision
207d
Days
Class 1
Risk

About This 510(k) Submission

K051114 is an FDA 510(k) clearance for the SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on November 25, 2005, 207 days after receiving the submission on May 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K051114 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2005
Decision Date November 25, 2005
Days to Decision 207 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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