510(k) K001411 ยท CEW Radioimmunoassay, Parathyroid Hormone
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
| Applicant | Scantibodies Laboratory, Inc., Santee CA, US |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | May 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001411
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.