ClearanceBrief
510(k) K021877 ยท GHH Fibrin Split Products

MDA D-DIMER

ApplicantbioMerieux, Inc., Durham NC, US
DecisionSubstantially Equivalent, Aug 7, 2002
ReceivedJun 7, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K021877

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.