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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 K102740
Device Name NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Applicant Contact JOCELYN JENNINGS
Correspondent
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Correspondent Contact JOCELYN JENNINGS
Regulation Number866.1640
Classification Product Code
NQX  
Subsequent Product Code
OOI  
Date Received09/22/2010
Decision Date 05/20/2011
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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