The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Omadacycline 30µg (omc30).
| Device ID | K183298 |
| 510k Number | K183298 |
| Device Name: | HardyDisk AST Omadacycline 30µg (OMC30) |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Contact | Anna Klavins |
| Correspondent | Anna Klavins Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-27 |
| Decision Date | 2019-01-18 |