The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Meropenem/vaborbactam 20/10µg (mev30).
| Device ID | K172621 |
| 510k Number | K172621 |
| Device Name: | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Hardy Diagnostics 1430 West McCoy Lane Santa Maria, CA 93455 |
| Contact | Andre Hsiung |
| Correspondent | Andre Hsiung 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 | 2017-08-31 |
| Decision Date | 2017-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816576023509 | K172621 | 000 |
| 00816576023493 | K172621 | 000 |