510(k) K143206
K143206 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "AmpliVue Bordetella Assay". The FDA issued a decision of Substantially Equivalent on December 10, 2014. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2014
- Date Received
- November 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bordetella Pertussis Dna Assay System
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.