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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 K870197
Device Name KDI QUIK TEST(TM) MARIJUANA SCREEN
Applicant
Keystone Diagnostics, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN B DUBECK
Correspondent
Keystone Diagnostics, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN B DUBECK
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received01/20/1987
Decision Date 06/01/1987
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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