Cleared Traditional

VITALAB DIRECT BILIRUBIN REAGENT

K040631 · Clinical Data, Inc. · Chemistry
Mar 2004
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K040631 is an FDA 510(k) clearance for the VITALAB DIRECT BILIRUBIN REAGENT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on March 18, 2004, 8 days after receiving the submission on March 10, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K040631 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2004
Decision Date March 18, 2004
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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