FDA Product Code ORI: Levetiracetam Assay
For The Quantitative Determination Of Levetiracetam In Human Serum Or Plasma.
Leading manufacturers include ARK Diagnostics, Inc..
2
Total
2
Cleared
170d
Avg days
2009
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Levetiracetam Assay Devices (Product Code ORI)
2 devices
Cleared
Feb 27, 2024
ARK Levetiracetam II Assay
ARK Diagnostics, Inc.
Toxicology
193d
Cleared
Nov 02, 2009
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
ARK Diagnostics, Inc.
Toxicology
146d
About Product Code ORI - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code ORI since 2009, with 2 receiving FDA clearance (average review time: 170 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.