510(k) K162911
K162911 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia RSV FIA on Sofia 2 analyzer". The FDA issued a decision of Substantially Equivalent on February 22, 2017. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2017
- Date Received
- October 17, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device Class
- Class I
- Regulation Number
- 866.3480
- Review Panel
- MI
- Submission Type