The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Veritor System For The Rapid Detection Of Rsv.
| Device ID | K133140 |
| 510k Number | K133140 |
| Device Name: | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2013-11-15 |
| Summary: | summary |