The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Directigen Ez Rsv.
| Device ID | K101514 |
| 510k Number | K101514 |
| Device Name: | BD DIRECTIGEN EZ RSV |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | BECTON DICKINSON & CO. 11085 NORTH TORREY PINES RD SUITE 210 La Jolla, CA 92037 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne BECTON DICKINSON & CO. 11085 NORTH TORREY PINES RD SUITE 210 La Jolla, CA 92037 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-07-09 |
| Summary: | summary |