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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, Cocaine And Cocaine Metabolites
510(k) Number K883105
Device Name EZ-SCREEN CANNABINOID/COCAINE
Applicant
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Applicant Contact GOLDEN, PH.D.
Correspondent
Environmental Diagnostics, Inc.
P.O. Box 908
1238 Anthony Rd.
Burlington,  NC  27215
Correspondent Contact GOLDEN, PH.D.
Regulation Number862.3250
Classification Product Code
DIO  
Date Received07/25/1988
Decision Date 12/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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