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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, Amphetamine
510(k) Number K981197
Device Name ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
Applicant
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Applicant Contact JACK L ARONOWITZ .
Correspondent
Tcpi, Inc.
P.O. Box 8726
Ft. Lauderdale,  FL  33310
Correspondent Contact JACK L ARONOWITZ .
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received04/02/1998
Decision Date 06/16/1998
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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