ClearanceBrief
510(k) K091884 ยท NWM Immunoassay, Anti-Seizure Drug

ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

ApplicantArk Diagnostics, Inc., Sunnyvale CA, US
DecisionSubstantially Equivalent, Dec 9, 2009
ReceivedJun 24, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K091884

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.