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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K935285
Device Name DRUGS OF ABUSE CONTROLS
Applicant
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Applicant Contact MICHAEL D BICK, PH.D
Correspondent
Medical Diagnostic Technologies, Inc.
6025 Nicolle St.
Ventura,  CA  93003
Correspondent Contact MICHAEL D BICK, PH.D
Regulation Number862.3280
Classification Product Code
DIF  
Date Received11/03/1993
Decision Date 03/22/1994
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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