The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test.
| Device ID | K070804 |
| 510k Number | K070804 |
| Device Name: | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST |
| Classification | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Sue Kent |
| Correspondent | Sue Kent NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| 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 | 2007-03-23 |
| Decision Date | 2007-09-17 |
| Summary: | summary |