Meprobamate Test System

QBK · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3590

Classification

FDA Product Code: QBK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3590
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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).

Market data

Cleared 510(k) submissions: 2
Registered establishments: 4

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown