510(k) K153012
K153012 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Sofia Influenza A+B FIA". The FDA issued a decision of Substantially Equivalent on January 12, 2016. The device falls under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens), a Class II device regulated under 21 CFR 866.3328. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2016
- Date Received
- October 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Device Class
- Class II
- Regulation Number
- 866.3328
- Review Panel
- MI
- Submission Type
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.