The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quickvue Influenza A/b Test.
| Device ID | K991633 |
| 510k Number | K991633 |
| 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 | Mary De Armond |
| Correspondent | Mary De Armond 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 | 1999-05-12 |
| Decision Date | 1999-09-24 |
| Summary: | summary |