510(k) K942369 ยท CEW Radioimmunoassay, Parathyroid Hormone
GAMMA-BCT INTACT PTH
| Applicant | Immunodiagnostic Systems , Ltd., Tyne And Wear, GB |
| Decision | Substantially Equivalent, Sep 20, 1994 |
| Received | May 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942369
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.