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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 K925183
Device Name BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST
Applicant
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG
Correspondent
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG
Regulation Number866.5640
Classification Product Code
KTN  
Date Received10/14/1992
Decision Date 02/23/1993
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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