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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 K894793
Device Name MONODEX
Applicant
Cenogenics Corp.
620 Route 520
Morganville,  NJ  07751
Applicant Contact MICHAEL KATZ
Correspondent
Cenogenics Corp.
620 Route 520
Morganville,  NJ  07751
Correspondent Contact MICHAEL KATZ
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/28/1989
Decision Date 08/21/1989
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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