SOFIA (R) STREP A+ FIA
FDA 510(k) clearance K141775 · decided 2014-12-16
Clearance details
- K-number
- K141775
- Device name
- SOFIA (R) STREP A+ FIA
- Applicant
- Quidel Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-07-01
- Decision date
- 2014-12-16
- Days to decision
- 168 days
- Clearance type
- Dual Track
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectio recall (Z-1598-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |