The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Sofia Analyzer And Influenza A+b Fia.
| Device ID | K112177 |
| 510k Number | K112177 |
| Device Name: | SOFIA ANALYZER AND INFLUENZA A+B FIA |
| 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 | 2011-07-28 |
| Decision Date | 2011-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613802211 | K112177 | 000 |
| 30014613202547 | K112177 | 000 |
| 30014613202219 | K112177 | 000 |
| 30014613202189 | K112177 | 000 |