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510(k) K102428

WUNDER TEST by Hien Helen Nguyen — Product Code LDJ

K102428 is an FDA 510(k) premarket notification submitted by Hien Helen Nguyen for the device "WUNDER TEST". The FDA issued a decision of Substantially Equivalent on April 18, 2012. The device falls under product code LDJ (Enzyme Immunoassay, Cannabinoids), a Class II device regulated under 21 CFR 862.3870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2012
Date Received
August 26, 2010
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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FDA data resources