510(k) K004038 ยท CEW Radioimmunoassay, Parathyroid Hormone
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
| Applicant | Scantibodies Laboratory, Inc., Santee CA, US |
| Decision | Substantially Equivalent, Apr 30, 2001 |
| Received | Dec 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004038
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.