SOFIA STREP A FIA
FDA 510(k) clearance K123793 · decided 2013-06-17
Clearance details
- K-number
- K123793
- Device name
- SOFIA STREP A FIA
- Applicant
- Quidel Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-12-10
- Decision date
- 2013-06-17
- Days to decision
- 189 days
- Clearance type
- Traditional
- 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
No recalls on record reference this clearance.