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QBK — Meprobamate Test System Class II

FDA Device Classification

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190397immunalysis corporationImmunalysis Carisoprodol Metabolite / Meprobamate Urine HEIANovember 15, 2019
DEN170010lin-zhi internationalLZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayApril 20, 2018