ClearanceBrief
510(k) K000716 ยท JHX Fluorometric Method, Cpk Or Isoenzymes

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

ApplicantBeckman Coulter, Inc., Chaska MN, US
DecisionSubstantially Equivalent, Mar 20, 2000
ReceivedMar 3, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K000716

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.