K131599 is an FDA 510(k) clearance for the QUICK VUE INFLUENZA. This device is classified as a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I - General Controls, product code GNX).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on July 5, 2013, 32 days after receiving the submission on June 3, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.
| 510(k) Number | K131599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2013 |
| Decision Date | July 05, 2013 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GNX — Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3330 |