HardyDisk AST Plazomicin 30ug (PLZ30) — Hardy Diagnostics (510(k) K181700)
HardyDisk AST Plazomicin 30ug (PLZ30) — Hardy Diagnostics (510(k) K181700) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HardyDisk AST Plazomicin 30ug (PLZ30); Applicant: Hardy Diagnostics; Clearance track: 510(k).
| Device name | HardyDisk AST Plazomicin 30ug (PLZ30) |
|---|---|
| Applicant | Hardy Diagnostics |
| Clearance track | 510(k) |
| Submission number | K181700 |
| Decision | Substantially Equivalent |
| Decision date | 2018-07-10 |
| Date received | 2018-06-27 |
| Product code | JTN |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CA, US |
| Source | openFDA device |
🔍 Search all device clearances →
$1999/mo
Try DeviceClear →