ClearanceBrief
510(k) K883544 ยท LSR Reagent, Borrelia Serological Reagent

LYME FAST TEST

Applicant3M Company, Santa Clara CA, US
DecisionSubstantially Equivalent, Jan 13, 1989
ReceivedAug 19, 1988
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K883544

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.