ClearanceBrief
510(k) K870462 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

EASY-TEST CREATINE KINASE-MB (CK-MB) #16615

ApplicantEm Diagnostic Systems, Inc., Gibbstown NJ, US
DecisionSubstantially Equivalent, Mar 10, 1987
ReceivedFeb 3, 1987
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K870462

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.