The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Delafloxacin 5 µg (dlx5).
| Device ID | K171975 |
| 510k Number | K171975 |
| Device Name: | HardyDisk AST Delafloxacin 5 µg (DLX5) |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Contact | Rianna Malherbe |
| Correspondent | Rianna Malherbe 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 | 2017-06-30 |
| Decision Date | 2017-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576023479 | K171975 | 000 |
| 00816576023462 | K171975 | 000 |