510(k) K091653
K091653 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00". The FDA issued a decision of Substantially Equivalent on November 2, 2009. The device falls under product code ORI (Levetiracetam Assay), a Class II device regulated under 21 CFR 862.3350. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
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.