510(k) K121633
K121633 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV". The FDA issued a decision of Substantially Equivalent on September 18, 2012. 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
- September 18, 2012
- Date Received
- June 4, 2012
- 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