Cleared Traditional

DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176

K904468 · Amresco, Inc. · Chemistry
Jan 1991
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K904468 is an FDA 510(k) clearance for the DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on January 17, 1991, 108 days after receiving the submission on October 1, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K904468 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1990
Decision Date January 17, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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