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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 K042392
Original Applicant
dalvagen 10
solna,  SW 16956
Original Contact anne bolmstrom
Regulation Number866.1640
Classification Product Code
Date Received09/02/2004
Decision Date 12/13/2004
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls