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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 K951892
Device Name ONE STEP URINE DRUG OF ABUSE COCAINE TEST
Applicant
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Applicant Contact CLECE W LAIRD
Correspondent
Tcpi, Inc.
3341 SW 15th St.
Pompano Beach,  FL  33069
Correspondent Contact CLECE W LAIRD
Regulation Number862.3250
Classification Product Code
DIO  
Date Received04/24/1995
Decision Date 08/17/1995
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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