QBK — Meprobamate Test System Class II
FDA product code QBK covers "Meprobamate Test System", a Class II medical device regulated under 21 CFR 862.3590. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBK
- Device Class
- Class II
- Regulation Number
- 862.3590
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).