510(k) K890615 ยท JHI Visual, Pregnancy Hcg, Prescription Use
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 18, 1989 |
| Received | Feb 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890615
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.