510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QBKClass II

Meprobamate Test System

21 CFR 862.3590 / Clinical Toxicology
FDA source (opens on fda.gov)

QBK is the FDA product code for Meprobamate Test System, a class II device type, regulated under 21 CFR 862.3590. FDA's definition for this code reads: "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)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBK
Device name
Meprobamate Test System
FDA 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).
Regulation
21 CFR 862.3590
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code QBK

By decision year
2 clearances under product code QBK with a decision year between 2018 and 2019, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBK by decision year
YearClearances
20181
20191

Applicants with the most clearances

Product code QBK
Applicants holding the most 510(k) clearances under product code QBK
ApplicantClearances
Immunalysis Corporation1
Lin-Zhi International Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code