Cleared Traditional

SENTINEL IRON LIQUID

K051115 · Sentinel Ch. Srl · Chemistry
Aug 2005
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K051115 is an FDA 510(k) clearance for the SENTINEL IRON LIQUID, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on August 25, 2005, 115 days after receiving the submission on May 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K051115 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2005
Decision Date August 25, 2005
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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