ClearanceBrief
510(k) K001035 ยท JWY Manual Antimicrobial Susceptibility Test Systems

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)

ApplicantTrek Diagnostic Systems, Inc., Westlake OH, US
DecisionSubstantially Equivalent, May 23, 2000
ReceivedMar 31, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001035

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.