BD Veritor™ System Flu A+B Assay
Devices Detecting Influenza A, B, And C Virus Antigens
Becton, Dickinson And Company
The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Veritor™ System Flu A+b Assay.
Pre-market Notification Details
| Device ID | K132693 |
| 510k Number | K132693 |
| Device Name: | BD Veritor™ System Flu A+B Assay |
| 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, Rac |
| Correspondent | Gregory P Payne, Rac 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 | 2013-08-29 |
| Decision Date | 2013-10-02 |
| Summary: | summary |
Trademark Results [BD Veritor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD VERITOR 85051782 4099717 Live/Registered |
Becton, Dickinson and Company 2010-06-01 |
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