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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cocaine Metabolite
510(k) Number K910123
Device Name TARGET COCAINE METABOLITE-V
Applicant
V-Tech, Inc.
9440 Telstar Ave., Suite 7
El Monte,  CA  91731
Applicant Contact WILLA BRUNKORST
Correspondent
V-Tech, Inc.
9440 Telstar Ave., Suite 7
El Monte,  CA  91731
Correspondent Contact WILLA BRUNKORST
Regulation Number862.3250
Classification Product Code
KLN  
Date Received01/11/1991
Decision Date 03/19/1991
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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