ClearanceBrief
510(k) K870461 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614

ApplicantEm Diagnostic Systems, Inc., Gibbstown NJ, US
DecisionSubstantially Equivalent, Mar 6, 1987
ReceivedFeb 3, 1987
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K870461

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.