ORH · Class II · 21 CFR 862.3350

FDA Product Code ORH: Lamotrigine Assay

For The Quantitative Determination Of Lamotrigine In Human Serum Or Plasma On Automated Clinical Chemistry Analyzers.

Leading manufacturers include Seradyn, Inc. and ARK Diagnostics, Inc..

2
Total
2
Cleared
139d
Avg days
2007
Since

FDA 510(k) Cleared Lamotrigine Assay Devices (Product Code ORH)

2 devices
1–2 of 2
Cleared Oct 29, 2010
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
K101305
ARK Diagnostics, Inc.
Toxicology · 172d
Cleared Jan 12, 2007
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
K062966
Seradyn, Inc.
Chemistry · 105d

About Product Code ORH - Regulatory Context