510(k) K910420 ยท JHI Visual, Pregnancy Hcg, Prescription Use
BIOCLONE'S ELEGANCE HCG ELISA KIT
| Applicant | Bioclone Australia Pty , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Feb 26, 1991 |
| Received | Jan 30, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910420
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.