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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 K883540
Device Name OXOID INFECTIOUS MONONUCLEOSIS KIT
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact MR. G ZAJICEK
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact MR. G ZAJICEK
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/18/1988
Decision Date 10/19/1988
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
Recalls CDRH Recalls
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