ClearanceBrief
510(k) K083799 ยท NWM Immunoassay, Anti-Seizure Drug

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

ApplicantArk Diagnostics, Inc., Sunnyvale CA, US
DecisionSubstantially Equivalent, Apr 16, 2009
ReceivedDec 22, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K083799

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.