510(k) K130213

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE by Lumiquick Diagnostics, Inc. — Product Code LDJ

K130213 is an FDA 510(k) premarket notification submitted by Lumiquick Diagnostics, Inc. for the device "QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE". The FDA issued a decision of Substantially Equivalent on October 18, 2013. 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
October 18, 2013
Date Received
January 29, 2013
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