510(k) K865057 ยท JHI Visual, Pregnancy Hcg, Prescription Use
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY
| Applicant | Hybritech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 10, 1987 |
| Received | Dec 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K865057
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.