ClearanceBrief
510(k) K801096 ยท KHM Nephelometric, Amylase

PERKIN ELMER MODEL 91 AMYLASE REAGENT

ApplicantStat Engineering, Mchenry IL, US
DecisionSubstantially Equivalent, Jun 9, 1980
ReceivedMay 9, 1980
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K801096

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.