Test, Barbiturate, Over The Counter
The Test, Barbiturate, Over The Counter is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine, available for over-the-counter use without a prescription, used in drug abuse monitoring and compliance testing. It is classified as FDA Class 2 under 21 CFR 862.3150 in the Clinical Toxicology specialty, requiring 510(k) premarket notification, and is eligible for third-party review. Product code PTH; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PTH
- Device Class
- FDA class 2
- Regulation Number
- 862.3150
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K180255 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Feb 28, 2018 | Substantially Equivalent | Hangzhou Clongene Biotech Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.