The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Sofia(r) Rsv Fia.
| Device ID | K130398 |
| 510k Number | K130398 |
| Device Name: | SOFIA(R) RSV FIA |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | John D Tamerius, Ph.d. |
| Correspondent | John D Tamerius, Ph.d. QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613202608 | K130398 | 000 |
| 30014613202424 | K130398 | 000 |