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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K981137
Device Name ETEST CEFOTAXIME
Applicant
AB BIODISK
DALVAGEN 10
SOLNA,  SE 16956
Applicant Contact ANNE BOLMSTROM
Correspondent
AB BIODISK
DALVAGEN 10
SOLNA,  SE 16956
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1640
Classification Product Code
JWY  
Date Received03/30/1998
Decision Date 06/09/1998
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
Recalls CDRH Recalls
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