Cleared Traditional

BILIRUBIN ASSAY ON THE OMNI S ANALYZER

K040174 · Roche Diagnostics Corp. · Chemistry
May 2004
Decision
109d
Days
Class 1
Risk

About This 510(k) Submission

K040174 is an FDA 510(k) clearance for the BILIRUBIN ASSAY ON THE OMNI S ANALYZER, a Bilirubin (total And Unbound) In The Neonate Test System (Class I — General Controls, product code MQM), submitted by Roche Diagnostics Corp. (Indianpolis, US). The FDA issued a Cleared decision on May 14, 2004, 109 days after receiving the submission on January 26, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1113.

Submission Details

510(k) Number K040174 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2004
Decision Date May 14, 2004
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MQM — Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1113

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