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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 K853105
Device Name IMMUNO-IM
Applicant
Immunostics Co., Inc.
212 Durham Ave.
Metuchen,  NJ  08840
Applicant Contact KENNETH KUPITS
Correspondent
Immunostics Co., Inc.
212 Durham Ave.
Metuchen,  NJ  08840
Correspondent Contact KENNETH KUPITS
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/23/1985
Decision Date 09/03/1985
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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