Cleared Traditional

WIENER LAB. BILIRUBINA DIRECT AA

K024116 · Wiener Laboratories Saic · Chemistry
Feb 2003
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K024116 is an FDA 510(k) clearance for the WIENER LAB. BILIRUBINA DIRECT AA, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on February 12, 2003, 61 days after receiving the submission on December 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K024116 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2002
Decision Date February 12, 2003
Days to Decision 61 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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