The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia Influenza A+b Fia.
| Device ID | K153012 |
| 510k Number | K153012 |
| Device Name: | Sofia Influenza A+B FIA |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | QUIDEL CORPORATION 12544 HIGH BLUFF DRIVE, SUITE 200 San Diego, CA 92130 |
| Contact | Edward C. Brehm |
| Correspondent | Edward C. Brehm QUIDEL CORPORATION 12544 HIGH BLUFF DRIVE, SUITE 200 San Diego, CA 92130 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-14 |
| Decision Date | 2016-01-12 |
| Summary: | summary |