Cleared Traditional

SENTINEL UIBC LIQUID

K051111 · Sentinel Ch. Srl · Chemistry
Nov 2005
Decision
199d
Days
Class 1
Risk

About This 510(k) Submission

K051111 is an FDA 510(k) clearance for the SENTINEL UIBC LIQUID, a Bathophenanthroline, Iron Binding Capacity (Class I — General Controls, product code JQF), submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on November 17, 2005, 199 days after receiving the submission on May 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K051111 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2005
Decision Date November 17, 2005
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JQF — Bathophenanthroline, Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415