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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
Device Name DAPTOMYCIN
Original Applicant
AB BIODISK
dalvagen 10
solna,  SW 16956
Original Contact anne bolmstrom
Regulation Number866.1640
Classification Product Code
JWY  
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
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