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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 K895765
Device Name LEECO PREVIEW(R) EBV (EIA)
Applicant
Leeco Diagnostics, Inc.
24475 W. Ten Mile Rd.
Southfield,  MI  48034
Applicant Contact DANTE J CAPALDI,PHD
Correspondent
Leeco Diagnostics, Inc.
24475 W. Ten Mile Rd.
Southfield,  MI  48034
Correspondent Contact DANTE J CAPALDI,PHD
Regulation Number866.5640
Classification Product Code
KTN  
Date Received09/26/1989
Decision Date 10/31/1989
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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