510(k) DEN170010
DEN170010 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay". The FDA issued a decision of De Novo Granted on April 20, 2018. The device falls under product code QBK (Meprobamate Test System), a Class II device regulated under 21 CFR 862.3590. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 20, 2018
- Date Received
- February 21, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meprobamate Test System
- Device Class
- Class II
- Regulation Number
- 862.3590
- Review Panel
- TX
- Submission Type
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).