ClearanceBrief
510(k) K872063 ยท JHY Colorimetric Method, Cpk Or Isoenzymes

TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II

ApplicantHybritech, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Jun 19, 1987
ReceivedMay 28, 1987
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K872063

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.