510(k) K060348 ยท CEW Radioimmunoassay, Parathyroid Hormone
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
| Applicant | Scantibodies Laboratory, Inc., Santee CA, US |
| Decision | Substantially Equivalent, Feb 27, 2006 |
| Received | Feb 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060348
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.