Cleared Traditional

COULTER DIRECT BILLRUBIN REAGENT

K905622 · Coulter Electronics, Inc. · Chemistry
Dec 1990
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K905622 is an FDA 510(k) clearance for the COULTER DIRECT BILLRUBIN REAGENT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 26, 1990, 12 days after receiving the submission on December 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K905622 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1990
Decision Date December 26, 1990
Days to Decision 12 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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