Cleared Traditional

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

K030003 · Elan Diagnostics · Chemistry
Sep 2003
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K030003 is an FDA 510(k) clearance for the ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on September 29, 2003, 270 days after receiving the submission on January 2, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K030003 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2003
Decision Date September 29, 2003
Days to Decision 270 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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