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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt
510(K) Number K120563
Device Name KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
Applicant
MICROPHAGE, INC.
2400 trade centre ave
longmont,  CO  80503
Contact drew smith
Regulation Number866.2050
Classification Product Code
OUS  
Date Received02/24/2012
Decision Date 03/30/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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