Cleared Traditional

TOTAL BILIRUBIN REAGENT SET

K040391 · Pointe Scientific, Inc., · Chemistry
Jun 2004
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K040391 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT SET, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on June 2, 2004, 106 days after receiving the submission on February 17, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K040391 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2004
Decision Date June 02, 2004
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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