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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 K862817
Device Name V-TREND QC TDM CONTROL SERUM 1,2,3.
Applicant
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Applicant Contact CHARLES W GILL
Correspondent
Texas Immunology, Inc.
5400 Spur 248
Tyler,  TX  75707
Correspondent Contact CHARLES W GILL
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/24/1986
Decision Date 08/19/1986
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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