PTH — Test, Barbiturate, Over The Counter Class II
FDA product code PTH covers "Test, Barbiturate, Over The Counter", a Class II medical device regulated under 21 CFR 862.3150. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K180255 | hangzhou clongene biotech co | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | February 28, 2018 |