The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia Strep A+ Fia, Sofia 2 Analyzer.
| Device ID | K171976 |
| 510k Number | K171976 |
| Device Name: | Sofia Strep A+ FIA, Sofia 2 Analyzer |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| 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 | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-12-21 |
| Summary: | summary |