The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Cefiderocol 30ug (fdc30).
| Device ID | K193504 |
| 510k Number | K193504 |
| Device Name: | HardyDisk AST Cefiderocol 30ug (FDC30) |
| 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 | 2019-12-18 |
| Decision Date | 2020-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398028097 | K193504 | 000 |