510(k) K850159 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 4, 1985 |
| Received | Jan 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850159
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.