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 Flu A+b.
| Device ID | K151291 |
| 510k Number | K151291 |
| Device Name: | BD Veritor (TM) System For The Rapid Detection Of Flu A+B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BECTON DICKINSON AND COMPANY 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne BECTON DICKINSON AND COMPANY 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-15 |
| Decision Date | 2015-06-10 |
| Summary: | summary |