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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
Applicant Contact DREW SMITH
Correspondent
Microphage, Inc.
2400 Trade Centre Ave.
Longmont,  CO  80503
Correspondent Contact DREW SMITH
Regulation Number866.2050
Classification Product Code
OUS  
Date Received02/24/2012
Decision Date 03/30/2012
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
Predetermined Change
Control Plan Authorized		 No
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