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510(k) K143535

CR3 Keyless Split Sample Cup Secobarbital- Methadone by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2015
Date Received
December 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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