ClearanceBrief
510(k) K000578 ยท LJX Test, Urine Leukocyte

SERIM LEUKOCYTE ESTERASE TEST STRIPS

ApplicantSerim Research Corp., Elkhart IN, US
DecisionSubstantially Equivalent, May 5, 2000
ReceivedFeb 22, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000578

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.