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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K861452
Device Name MONOSTAR SYSTEM: IM LATEX TEST
Applicant
U.S. Health Resources Corp.
16101 N. W. 57th. Ave.
Miami,  FL  33014
Applicant Contact BRUCE CLINTON
Correspondent
U.S. Health Resources Corp.
16101 N. W. 57th. Ave.
Miami,  FL  33014
Correspondent Contact BRUCE CLINTON
Regulation Number866.5640
Classification Product Code
KTN  
Date Received04/18/1986
Decision Date 05/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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