Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
FDA 510(k) clearance K143651 · decided 2015-03-18
Clearance details
- K-number
- K143651
- Device name
- Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-23
- Decision date
- 2015-03-18
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- PGX
- Device class
- 2
- Regulation number
- 866.2680
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, recall (Z-1274-2016) | Focus Diagnostics Inc | 2016-04-02 |