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ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

Ark Diagnostics, Inc. · Class II · Cleared Nov 2, 2009

K-numberK091653
Device nameARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
ApplicantArk Diagnostics, Inc.
Product codeORI
Device classClass II
Decision dateNov 2, 2009
DecisionSubstantially Equivalent
Regulation862.3350
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