ClearanceBrief
510(k) K934863 ยท LYR Helicobacter Pylori

FLEXSURE HP

ApplicantSmithkline Diagnostics, Inc., San Jose CA, US
DecisionSubstantially Equivalent, May 18, 1994
ReceivedOct 12, 1993
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K934863

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.