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510(k) K180255

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup by Hangzhou Clongene Biotech Co., Ltd. — Product Code PTH

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.

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