510(k) K180255
K180255 is an FDA 510(k) premarket notification submitted by Hangzhou Clongene Biotech Co., Ltd. for the device "CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup". The FDA issued a decision of Substantially Equivalent on February 28, 2018. The device falls under product code PTH (Test, Barbiturate, Over The Counter), a Class II device regulated under 21 CFR 862.3150. Hangzhou Clongene Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2018
- Date Received
- January 30, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Barbiturate, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type
The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.