SIMPLEXA HSV 1&2 DIRECT
FDA 510(k) clearance DEN130049 · decided 2014-03-21
Clearance details
- K-number
- DEN130049
- Device name
- SIMPLEXA HSV 1&2 DIRECT
- Applicant
- Focus Diagnostics
- Decision
- Unknown
- Date received
- 2013-11-25
- Decision date
- 2014-03-21
- Days to decision
- 116 days
- Clearance type
- Direct
- Product code
- PGH
- Device class
- 2
- Regulation number
- 866.3307
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- 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 |
|---|---|---|
| miDiagnostics HSV-1&2 CSF Test (K250050) | Midiagnostics NV | 2025-09-30 |
| SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458) | Focus Diagnostics | 2014-07-01 |
Recalls involving this device
No recalls on record reference this clearance.