The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Influenza A + B Test.
| Device ID | K053146 |
| 510k Number | K053146 |
| Device Name: | QUICKVUE INFLUENZA A + B TEST |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | John D Tamerius |
| Correspondent | John D Tamerius QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-10 |
| Decision Date | 2005-12-14 |
| Summary: | summary |