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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 K102342
Device Name KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
Applicant
MICROPHAGE, INC.
2400 TRADE CENTRE AVENUE
LONGMONT,  CO  80503
Applicant Contact DREW SMITH
Correspondent
MICROPHAGE, INC.
2400 TRADE CENTRE AVENUE
LONGMONT,  CO  80503
Correspondent Contact DREW SMITH
Regulation Number866.2050
Classification Product Code
OUS  
Date Received08/18/2010
Decision Date 05/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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