510(k) K913122 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DIRECTIGEN 1-2-3(TM) HCG TEST
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | Jul 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913122
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.