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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name real time nucleic acid amplification system
510(k) Number K093383
Device Name NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
Applicant
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Applicant Contact MARIA OYASKI
Correspondent
BIOMERIEUX, INC.
100 RODOLPHE ST
DURHAM,  NC  27712
Correspondent Contact MARIA OYASKI
Regulation Number862.2570
Classification Product Code
OOI  
Date Received10/30/2009
Decision Date 07/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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