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510(k) K121557

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
May 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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