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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 K972457
Device Name MONOCOL/LEX-IM TEST
Applicant
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact DAVID MYCOCK
Correspondent
Immunostics Inc.,
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact DAVID MYCOCK
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/01/1997
Decision Date 12/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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