510(k) K031534 ยท CEW Radioimmunoassay, Parathyroid Hormone
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
| Applicant | Scantibodies Laboratory, Inc., Santee CA, US |
| Decision | Substantially Equivalent, Jul 30, 2003 |
| Received | May 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031534
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.