SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
FDA 510(k) clearance K141458 · decided 2014-07-01
Clearance details
- K-number
- K141458
- Device name
- SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
- Applicant
- Focus Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2014-06-02
- Decision date
- 2014-07-01
- Days to decision
- 29 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Focus Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (DEN130049) | Focus Diagnostics | 2014-03-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Produc recall (Z-2547-2020) | DiaSorin Molecular LLC | 2020-07-10 |
| Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL145 recall (Z-1272-2016) | Focus Diagnostics Inc | 2016-04-02 |