Cleared Traditional

ADVIA CHEMISTRY TOTAL BILIRUBIN_2

K063845 · Bayer Healthcare, LLC · Chemistry
Dec 2007
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K063845 is an FDA 510(k) clearance for the ADVIA CHEMISTRY TOTAL BILIRUBIN_2, a Enzymatic Method, Bilirubin (Class II — Special Controls, product code JFM), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 7, 2007, 345 days after receiving the submission on December 27, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K063845 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2006
Decision Date December 07, 2007
Days to Decision 345 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFM — Enzymatic Method, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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