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510(k) K050024

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS by Guangzhou Wondfo Biotech Co., Ltd. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2005
Date Received
January 5, 2005
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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