Cleared Traditional

TOTAL BILIRUBIN REAGENT SET

K910635 · Biochemical Trade, Inc. · Chemistry
May 1991
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K910635 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT SET, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on May 15, 1991, 92 days after receiving the submission on February 12, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K910635 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1991
Decision Date May 15, 1991
Days to Decision 92 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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