510(k) K101305
K101305 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL". The FDA issued a decision of Substantially Equivalent on October 29, 2010. The device falls under product code ORH (Lamotrigine 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
- October 29, 2010
- Date Received
- May 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamotrigine Assay
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.