The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Imipenem/relebactam 10/25µg (imr10/25).
| Device ID | K191931 |
| 510k Number | K191931 |
| Device Name: | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) |
| 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 | 2019-07-19 |
| Decision Date | 2019-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398028165 | K191931 | 000 |
| 00819398028158 | K191931 | 000 |