Cleared Traditional

TOTAL BILIRUBIN

K840111 · Fisher Scientific Co., LLC · Chemistry
Mar 1984
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K840111 is an FDA 510(k) clearance for the TOTAL BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984, 69 days after receiving the submission on January 10, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K840111 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1984
Decision Date March 19, 1984
Days to Decision 69 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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