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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 K001547
Device Name ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
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 Received05/18/2000
Decision Date 08/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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