OTF · Class II · 21 CFR 862.3350

FDA Product Code OTF: Gabapentin Assay

Test For The Quantitative Determination Of Gabapentin In Human Serum Or Plasma. Gabapentin Concentrations Can Be Used As An Aid In Management Of Patients Treated With Gabapentin.

Leading manufacturers include ARK Diagnostics, Inc..

1
Total
1
Cleared
169d
Avg days
2010
Since

FDA 510(k) Cleared Gabapentin Assay Devices (Product Code OTF)

1 devices
1–1 of 1
Cleared Nov 23, 2010
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
K101574
ARK Diagnostics, Inc.
Toxicology · 169d

About Product Code OTF - Regulatory Context