The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Veritor(tm) System For Rapid Detection Of Flu A+b.
| Device ID | K112277 |
| 510k Number | K112277 |
| Device Name: | BD VERITOR(TM) SYSTEM FOR 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 92064 |
| Contact | Gregory P Payne |
| Correspondent | Gregory P Payne Becton, Dickinson And Company 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92064 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902560746 | K112277 | 000 |
| 00382902560715 | K112277 | 000 |
| 00382902560456 | K112277 | 000 |