The following data is part of a premarket notification filed by Bd with the FDA for Bd Veritor System For Rapid Detection Of Flu A + B Clia Waived Kit.
| Device ID | K180438 |
| 510k Number | K180438 |
| Device Name: | BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived Kit |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BD 10865 Road To The Cure San Diego, CA 92121 |
| Contact | Brad Spring |
| Correspondent | Mary Ann Fiechtner BD 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 | 2018-02-20 |
| Decision Date | 2018-03-20 |
| Summary: | summary |