510(k) K831221 ยท JHI Visual, Pregnancy Hcg, Prescription Use
RIAGEN B-HCG RIA KIT
| Applicant | Biogenex Laboratories, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 2, 1983 |
| Received | Apr 15, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831221
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.