510(k) K150602

CR3 Keyless Split Sample Cup Morphine - Methamphetamine by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2015
Date Received
March 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type