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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K970768
Device Name HUMAN LYME IGM WESTERN BLOT KIT
Applicant
Cambridge Diagnostics Ireland, Ltd.
Mervue Business Park
Galway,  IE
Applicant Contact SILE MACMAHON
Correspondent
Cambridge Diagnostics Ireland, Ltd.
Mervue Business Park
Galway,  IE
Correspondent Contact SILE MACMAHON
Regulation Number866.3830
Classification Product Code
LSR  
Date Received03/03/1997
Decision Date 04/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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