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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 K980836
Device Name GENIE CUP INTEGRATED SCREENING DEVICE
Applicant
Applied Technology Ventures, LLC
6 Taft Ct., Suite 150
Rockville,  MD  20850
Applicant Contact RICHARD ROBLIN
Correspondent
Applied Technology Ventures, LLC
6 Taft Ct., Suite 150
Rockville,  MD  20850
Correspondent Contact RICHARD ROBLIN
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJG   DKZ   LCM  
Date Received03/04/1998
Decision Date 06/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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