The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia Strep A Fia.
| Device ID | K123793 |
| 510k Number | K123793 |
| Device Name: | SOFIA STREP A FIA |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | John D Tamerius, Ph.d. |
| Correspondent | John D Tamerius, Ph.d. QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613202530 | K123793 | 000 |
| 30014613202318 | K123793 | 000 |