510(k) K131166 ยท JHI Visual, Pregnancy Hcg, Prescription Use
SOFIA(R) HCG FIA
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 2, 2013 |
| Received | Apr 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131166
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.