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510(k) K140089

CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2014
Date Received
January 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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