ClearanceBrief
510(k) K901924 ยท LLL Extractable Antinuclear Antibody, Antigen And Control

READS(R) ANTI-ENA (SM/RNP) TEST KIT

ApplicantBiosearch Medical Products, Inc., Boulder CO, US
DecisionSubstantially Equivalent, May 9, 1990
ReceivedApr 30, 1990
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K901924

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.