The following data is part of a premarket notification filed by Osmetech Molecular Diagnostics with the FDA for Esensor Warfarin Sensitivity And Xt-8 Instrument.
| Device ID | K073720 |
| 510k Number | K073720 |
| Device Name: | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT |
| Classification | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Applicant | OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Contact | Robert Dicheck |
| Correspondent | Robert Dicheck OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena, CA 91105 |
| Product Code | ODW |
| Subsequent Product Code | NSU |
| Subsequent Product Code | ODV |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-07-17 |
| Summary: | summary |