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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K130213
Device Name QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
Applicant
Lumiquick Diagnostics, Inc.
27001 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Applicant Contact Feng-Yu Lee
Correspondent
Lumiquick Diagnostics, Inc.
27001 La Paz Rd.
Suite 266b
Mission Viejo,  CA  92691
Correspondent Contact Feng-Yu Lee
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DKZ   JXM   LCM  
Date Received01/29/2013
Decision Date 10/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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