The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Veritor(tm) System For The Rapid Detection Of Rsv.
| Device ID | K121633 |
| 510k Number | K121633 |
| Device Name: | BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | Becton, Dickinson And Company 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92064 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne Becton, Dickinson And Company 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92064 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-04 |
| Decision Date | 2012-09-18 |
| Summary: | summary |