QBF · Class II · 21 CFR 862.3700

FDA Product Code QBF: Test, Propoxyphene, Over The Counter

The Propoxyphene Test Is An In Vitro Diagnostic Test For The Qualitative Detection Of Propoxyphene In Human Urine. The Test Is Intended For Over-the-counter Use As The First Step In A Two Step Process To Provide Consumers With Information Concerning The Presence Or Absence Of Propoxyphene In A Urine Sample.

Leading manufacturers include W.H.P.M., Inc..

1
Total
1
Cleared
189d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Test, Propoxyphene, Over The Counter Devices (Product Code QBF)

1 devices
1–1 of 1
Cleared Aug 12, 2021
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup
K210327
W.H.P.M., Inc.
Toxicology · 189d

About Product Code QBF - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QBF since 2021, with 1 receiving FDA clearance (average review time: 189 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

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