miDiagnostics HSV-1&2 CSF Test
FDA 510(k) clearance K250050 · decided 2025-09-30
Clearance details
- K-number
- K250050
- Device name
- miDiagnostics HSV-1&2 CSF Test
- Applicant
- Midiagnostics NV
- Decision
- Substantially Equivalent
- Date received
- 2025-01-10
- Decision date
- 2025-09-30
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- PGH
- Device class
- 2
- Regulation number
- 866.3307
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458) | Focus Diagnostics | 2014-07-01 |
| SIMPLEXA HSV 1&2 DIRECT (DEN130049) | Focus Diagnostics | 2014-03-21 |
Recalls involving this device
No recalls on record reference this clearance.