K171976 is an FDA 510(k) clearance for the Sofia Strep A+ FIA, Sofia 2 Analyzer. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on December 21, 2017, 174 days after receiving the submission on June 30, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K171976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 174 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |