The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Veritor System For Rapid Detection Of Flu A + B Labratory Kit.
| Device ID | K160164 |
| 510k Number | K160164 |
| Device Name: | BD Veritor System For Rapid Detection Of Flu A + B Labratory Kit |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| 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 | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-02-25 |
| Summary: | summary |