The following data is part of a premarket notification filed by Autogenomics, Incorporated with the FDA for Infiniti 2c9 & Vkorc1 Multiplex Assay For Warfarin.
| Device ID | K073014 |
| 510k Number | K073014 |
| Device Name: | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN |
| Classification | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Applicant | AUTOGENOMICS, INCORPORATED 2251 RUTHERFORD ROAD Carlsbad, CA 92008 |
| Contact | Evelyn G Lopez |
| Correspondent | Evelyn G Lopez AUTOGENOMICS, INCORPORATED 2251 RUTHERFORD ROAD Carlsbad, CA 92008 |
| Product Code | ODW |
| Subsequent Product Code | NSU |
| Subsequent Product Code | ODV |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-25 |
| Decision Date | 2008-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850009370181 | K073014 | 000 |
| 00850009370174 | K073014 | 000 |
| 00850009370167 | K073014 | 000 |