ClearanceBrief
510(k) K973869 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt

TRACE REAGENT LINE FOR THE COBAS MIRA

ApplicantTrace America, Inc., Miami FL, US
DecisionSubstantially Equivalent, Jan 7, 1998
ReceivedSep 24, 1997
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K973869

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.