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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 K771397
Device Name MONOSTICON TEST
Applicant
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/29/1977
Decision Date 08/22/1977
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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