Cleared Traditional

Total Bilirubin

K150510 · Abbott Laboratories · Chemistry
Apr 2015
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K150510 is an FDA 510(k) clearance for the Total Bilirubin, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 2, 2015, 34 days after receiving the submission on February 27, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K150510 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2015
Decision Date April 02, 2015
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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