510(k) K171976
K171976 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia Strep A+ FIA, Sofia 2 Analyzer". The FDA issued a decision of Substantially Equivalent on December 21, 2017. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2017
- Date Received
- June 30, 2017
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, All Groups, Streptococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type