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510(k) K091653

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 by ARK Diagnostics, Inc. — Product Code ORI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2009
Date Received
June 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Levetiracetam Assay
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

For the quantitative determination of levetiracetam in human serum or plasma.

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Other clearances for product code ORI

  • K232522 — ARK Levetiracetam II Assay (February 27, 2024)