Cleared Traditional

Direct Bilirubin

K152343 · Randox Laboratories Limited · Chemistry
Feb 2016
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K152343 is an FDA 510(k) clearance for the Direct Bilirubin, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on February 16, 2016, 181 days after receiving the submission on August 19, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K152343 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2015
Decision Date February 16, 2016
Days to Decision 181 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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