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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 K954291
Device Name OPUS TDM CONTROLS
Applicant
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Behring Diagnostics, Inc.
151 University Ave.
Westwood,  MA  02090
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/14/1995
Decision Date 11/20/1995
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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