The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Sofia(r) Hcg Fia.
| Device ID | K131166 |
| 510k Number | K131166 |
| Device Name: | SOFIA(R) HCG FIA |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613202660 | K131166 | 000 |
| 30014613202295 | K131166 | 000 |