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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 K913459
Device Name THE E TEST, MODIFICATION
Applicant
AB BIODISK
PYRAMIDVAGEN 7
SOLNA,  SE S-171 36
Applicant Contact ANNE BOLMSTROM
Correspondent
AB BIODISK
PYRAMIDVAGEN 7
SOLNA,  SE S-171 36
Correspondent Contact ANNE BOLMSTROM
Regulation Number866.1640
Classification Product Code
JWY  
Date Received08/05/1991
Decision Date 09/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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