K123793 is an FDA 510(k) clearance for the SOFIA STREP A FIA. 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 June 17, 2013, 189 days after receiving the submission on December 10, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K123793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2012 |
| Decision Date | June 17, 2013 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| 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 |