PTH — Test, Barbiturate, Over The Counter Class II

FDA Device Classification

Classification Details

Product Code
PTH
Device Class
Class II
Regulation Number
862.3150
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Definition

The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K180255hangzhou clongene biotech coCLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupFebruary 28, 2018