ClearanceBrief
510(k) K053243 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

ApplicantTrek Diagnostic Systems, Inc., Cleveland OH, US
DecisionSubstantially Equivalent, Jan 20, 2006
ReceivedNov 21, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K053243

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.