510(k) K132456
K132456 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV". The FDA issued a decision of Substantially Equivalent on November 7, 2013. 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. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2013
- Date Received
- August 6, 2013
- 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