Cleared Traditional

DIAZO COLORIMENTRY DIRECT BILIRUBIN

K904381 · Amresco, Inc. · Chemistry
Oct 1990
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K904381 is an FDA 510(k) clearance for the DIAZO COLORIMENTRY DIRECT BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on October 12, 1990, 16 days after receiving the submission on September 26, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K904381 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 1990
Decision Date October 12, 1990
Days to Decision 16 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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