QBK · Class II · 21 CFR 862.3590

FDA Product Code QBK: Meprobamate Test System

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).

Leading manufacturers include Lin-Zhi International, Inc. and Immunalysis Corporation.

2
Total
1
Cleared
346d
Avg days
2018
Since

FDA 510(k) Cleared Meprobamate Test System Devices (Product Code QBK)

2 devices
1–2 of 2
Cleared Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397
Immunalysis Corporation
Toxicology · 269d
Not Cleared Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
DEN170010
Lin-Zhi International, Inc.
Toxicology · 423d

About Product Code QBK - Regulatory Context

QBK devices are reviewed by the Toxicology panel. Browse all Toxicology devices →