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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 K853388
Device Name MONOSTICON UNI-DOT
Applicant
Organon, Inc.
West Orange,  NJ  07052
Applicant Contact PATRICK J OSINSKI
Correspondent
Organon, Inc.
West Orange,  NJ  07052
Correspondent Contact PATRICK J OSINSKI
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/13/1985
Decision Date 08/22/1985
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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