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ORI — Levetiracetam Assay Class II

FDA Device Classification

Classification Details

Product Code
ORI
Device Class
Class II
Regulation Number
862.3350
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232522ark diagnosticsARK Levetiracetam II AssayFebruary 27, 2024
K091653ark diagnosticsARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTNovember 2, 2009