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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 K140546
Device Name HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
Applicant
HEALGEN SCIENTIFIC, LLC
504 EAST DIAMOND AVE.
SUITE F
GAITHERSBURG,  MD  20877
Applicant Contact Joe Shia
Correspondent
HEALGEN SCIENTIFIC, LLC
504 EAST DIAMOND AVE.
SUITE F
GAITHERSBURG,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
LAF  
Date Received03/04/2014
Decision Date 06/06/2014
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
Recalls CDRH Recalls
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