Cleared Traditional

Total Bilirubin

K152344 · Randox Laboratories Limited · Chemistry
Jan 2016
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K152344 is an FDA 510(k) clearance for the Total Bilirubin, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Randox Laboratories Limited (Crumlin, County Antrim, GB). The FDA issued a Cleared decision on January 28, 2016, 162 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 K152344 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2015
Decision Date January 28, 2016
Days to Decision 162 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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