The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Quick Vue Influenza.
| Device ID | K131599 |
| 510k Number | K131599 |
| Device Name: | QUICK VUE INFLUENZA |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | John D Tamerius, Ph.d. |
| Correspondent | John D Tamerius, Ph.d. QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2013-07-05 |
| Summary: | summary |