Cleared Traditional

DIRECT BILIRUBIN REAGENT

K011972 · Intersect Systems, Inc. · Chemistry
Aug 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K011972 is an FDA 510(k) clearance for the DIRECT 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 August 27, 2001, 63 days after receiving the submission on June 25, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K011972 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2001
Decision Date August 27, 2001
Days to Decision 63 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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