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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 K951853
Device Name ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
Applicant
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Applicant Contact CLEVE W LAIRD
Correspondent
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Correspondent Contact CLEVE W LAIRD
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received04/21/1995
Decision Date 08/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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