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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 K121122
Device Name DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL
Original Applicant
BIOCHEMICAL DIAGNOSTIC, INC.
180 heartland blvd.
edgewood,  NY  11717
Original Contact allen panetz
Regulation Number862.3280
Classification Product Code
DIF  
Date Received04/13/2012
Decision Date 07/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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