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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 K875219
Device Name MODIFICATION TO KDI QUIK TEST MARIJUANA SCREEN
Applicant
Keystone Diagnostics, Inc.
C/O Keller & Heckman
1150 17th St., NW, Suite 1000
Washington,  DC  20036
Applicant Contact JOHN DUBECK
Correspondent
Keystone Diagnostics, Inc.
C/O Keller & Heckman
1150 17th St., NW, Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN DUBECK
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received12/22/1987
Decision Date 06/24/1988
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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