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510(k) DEN170010

LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay by Lin-Zhi International, Inc. — Product Code QBK

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).

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