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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 K132468
Device Name MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
Applicant
ELITechGroup Epoch Biosciences
21720 23RD DR SE, SUITE 150
bothell,  WA  98021
Applicant Contact debra k hutson
Correspondent
ELITechGroup Epoch Biosciences
21720 23RD DR SE, SUITE 150
bothell,  WA  98021
Correspondent Contact debra k hutson
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Codes
JJH   NSU  
Date Received08/07/2013
Decision Date 10/17/2013
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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