HardyDisk AST Cefiderocol 30µg (FDC30)
FDA 510(k) clearance K253105 · decided 2025-11-20
Clearance details
- K-number
- K253105
- Device name
- HardyDisk AST Cefiderocol 30µg (FDC30)
- Applicant
- Hardy Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2025-09-24
- Decision date
- 2025-11-20
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Maria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for recall (Z-2887-2026) | Hardy Diagnostics | 2026-08-05 |