510(k) K831155 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
B-CLONE HCG ASSAY
| Applicant | Monoclonal Antibodies, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 2, 1983 |
| Received | Apr 8, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831155
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.