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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
510(k) Number K112937
Model M800346
Device Name MRSA/SA ELITE MGB
Original Applicant
ELITECH
21720 23rd drive se,
suite 150
bothell,  WA  98021
Original Contact debra k hutson
Regulation Number866.1640
Classification Product Code
NQX  
Date Received10/03/2011
Decision Date 06/01/2012
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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