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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 K981946
Device Name CLEARVIEW IM
Applicant
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Applicant Contact Louise Roberts
Correspondent
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Correspondent Contact Louise Roberts
Regulation Number866.5640
Classification Product Code
KTN  
Date Received06/03/1998
Decision Date 12/10/1998
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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