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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 K873297
Device Name DIFFERENTIAL I.M. SCREENING TEST
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/18/1987
Decision Date 12/14/1987
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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