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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 K872882
Device Name CANNABINOID ENZYME IMMUNOASSAY KIT
Applicant
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Applicant Contact SUSAN M DURHAM
Correspondent
General Diagnostics
160 Community Dr.
Great Neck,  NY  11021
Correspondent Contact SUSAN M DURHAM
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received07/22/1987
Decision Date 11/03/1987
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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