Cleared Traditional

TOTAL BILIRUBIN REAGENT

K972073 · Carolina Liquid Chemistries Corp. · Chemistry
Jun 1997
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K972073 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 24, 1997, 21 days after receiving the submission on June 3, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K972073 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1997
Decision Date June 24, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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