ClearanceBrief
510(k) K060348 ยท CEW Radioimmunoassay, Parathyroid Hormone

MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

ApplicantScantibodies Laboratory, Inc., Santee CA, US
DecisionSubstantially Equivalent, Feb 27, 2006
ReceivedFeb 10, 2006
TypeSpecial
FDA recordOpen 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.