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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 K883004
Device Name MONO-PLUS(TM)
Applicant
Wampole Laboratories
P.O. Box # 1
Cranbury,  NJ  08512
Applicant Contact ANN MACLEARIE
Correspondent
Wampole Laboratories
P.O. Box # 1
Cranbury,  NJ  08512
Correspondent Contact ANN MACLEARIE
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/18/1988
Decision Date 08/04/1988
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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