510(k) K801409 ยท JHI Visual, Pregnancy Hcg, Prescription Use
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 14, 1980 |
| Received | Jun 16, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801409
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.