K040174 is an FDA 510(k) clearance for the BILIRUBIN ASSAY ON THE OMNI S ANALYZER. This device is classified as a Bilirubin (total And Unbound) In The Neonate Test System (Class I - General Controls, product code MQM).
Submitted by Roche Diagnostics Corp. (Indianapolis, 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 FDA review panel. Regulated under 21 CFR 862.1113.
| 510(k) Number | K040174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MQM — Bilirubin (total And Unbound) In The Neonate Test System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1113 |