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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 K153474
Device Name Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
Applicant
Biochemical Diagnostics, Inc.
180 Heartland Blvd.
Edgewood,  NY  11717
Applicant Contact ALLEN PANETZ
Correspondent
Biochemical Diagnostics, Inc.
180 Heartland Blvd.
Edgewood,  NY  11717
Correspondent Contact ALLEN PANETZ
Regulation Number862.3280
Classification Product Code
DIF  
Date Received12/02/2015
Decision Date 02/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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