The following data is part of a premarket notification filed by Akonni Biosystems Inc. with the FDA for Trudiagnosis System.
| Device ID | K183530 |
| 510k Number | K183530 |
| Device Name: | TruDiagnosis System |
| Classification | Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Applicant | Akonni Biosystems Inc. 400 Sagner Ave, Suite 300 Frederick, MD 21701 |
| Contact | Charles Daitch |
| Correspondent | Rita King MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, NC 27560 |
| 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 | 2018-12-19 |
| Decision Date | 2019-05-24 |
| Summary: | summary |