K211342 is an FDA 510(k) clearance for the Sofia 2 Campylobacter FIA. This device is classified as a Campylobacter Spp. (Class I - General Controls, product code LQP).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on November 23, 2021, 204 days after receiving the submission on May 3, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K211342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2021 |
| Decision Date | November 23, 2021 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LQP — Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |