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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, All Types, Escherichia Coli
510(k) Number K971663
Device Name WELLCOLEX E.COLI O157:H7
Applicant
Murex Biotech , Ltd.
Central Rd., Temple Hill
Dartford,Kent,  GB DA1 5LR
Applicant Contact REBECCA VINE
Correspondent
Murex Biotech , Ltd.
Central Rd., Temple Hill
Dartford,Kent,  GB DA1 5LR
Correspondent Contact REBECCA VINE
Regulation Number866.3255
Classification Product Code
GMZ  
Date Received05/06/1997
Decision Date 12/30/1997
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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