OTF — Gabapentin Assay Class II
Classification Details
- Product Code
- OTF
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101574 | ark diagnostics | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODE | November 23, 2010 |