Cleared Traditional

TOTAL BILIRUBIN REAGENT

K003892 · Intersect Systems, Inc. · Chemistry
Feb 2001
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K003892 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on February 20, 2001, 64 days after receiving the submission on December 18, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K003892 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2000
Decision Date February 20, 2001
Days to Decision 64 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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