The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Quickvue Influenza A+b.
| Device ID | K180288 |
| 510k Number | K180288 |
| Device Name: | QuickVue Influenza A+B |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Quidel Corporation 10165 McKellar Court San Diego, CA 92121 |
| Contact | Jennifer S. Rial |
| Correspondent | Jennifer S. Rial Quidel Corporation 10165 McKellar Court 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 | 2018-02-01 |
| Decision Date | 2018-02-13 |
| Summary: | summary |