The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Bilirubin Assay On The Omni S Analyzer.
| Device ID | K040174 |
| 510k Number | K040174 |
| Device Name: | BILIRUBIN ASSAY ON THE OMNI S ANALYZER |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-05-14 |
| Summary: | summary |