510(k) K091653— ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

Substantially Equivalent

Ark Diagnostics, Inc.

Clearance details

Applicant: Ark Diagnostics, Inc.
Product code: Code ORI
Advisory panel: Clinical Toxicology
Date received: 2009-06-09
Decision date: 2009-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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