Cleared Traditional

AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)

K900571 · American Research Products Co. · Chemistry
Apr 1990
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K900571 is an FDA 510(k) clearance for the AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD), a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on April 16, 1990, 68 days after receiving the submission on February 7, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K900571 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1990
Decision Date April 16, 1990
Days to Decision 68 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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