ClearanceBrief
510(k) K822758 ยท GKL Counter, Cell, Automated (Particle Counter)

SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY

ApplicantToa Medical Electronics USA, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Oct 18, 1982
ReceivedSep 14, 1982
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K822758

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.