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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 K925586
Device Name DETECTABUSE(TM)
Applicant
Biochemical Diagnostic, Inc.
180 Heartland Blvd.
Edgewood,  NY  11717
Applicant Contact ALLEN PANETZ
Correspondent
Biochemical Diagnostic, Inc.
180 Heartland Blvd.
Edgewood,  NY  11717
Correspondent Contact ALLEN PANETZ
Regulation Number862.3280
Classification Product Code
DIF  
Date Received11/04/1992
Decision Date 12/28/1992
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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