Home / 510(k) Clearances / K141532

510(k) K141532

CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2014
Date Received
June 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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