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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 K982634
Device Name DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
Applicant
Oxoid , Ltd.
Wade Rd.
Basingstoke,  GB RG24 8PW
Applicant Contact ANDY HOLLINGSWORTH
Correspondent
Oxoid , Ltd.
Wade Rd.
Basingstoke,  GB RG24 8PW
Correspondent Contact ANDY HOLLINGSWORTH
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/28/1998
Decision Date 01/28/1999
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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