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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 K902541
Device Name MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
Applicant
Trinity Laboratories, Inc.
533 Pylon Dr.
Raleigh,  NC  27606
Applicant Contact BRUCE A CLINTON,PHD
Correspondent
Trinity Laboratories, Inc.
533 Pylon Dr.
Raleigh,  NC  27606
Correspondent Contact BRUCE A CLINTON,PHD
Regulation Number866.5640
Classification Product Code
KTN  
Date Received06/06/1990
Decision Date 06/28/1990
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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