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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 K872032
Device Name VENTRESCREEN (TM) MONO
Applicant
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Applicant Contact JAMES W CHAMPLIN
Correspondent
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Correspondent Contact JAMES W CHAMPLIN
Regulation Number866.5640
Classification Product Code
KTN  
Date Received05/27/1987
Decision Date 06/29/1987
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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