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 Rsv.
| Device ID | K132456 |
| 510k Number | K132456 |
| Device Name: | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| 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 | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-06 |
| Decision Date | 2013-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902560388 | K132456 | 000 |