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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
Model 200300, 280107, 20076, 200305, 285205
Device Name NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG
Original Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham,  NC  27712
Original Contact maria oyaski
Regulation Number862.2570
Classification Product Code
OOI  
Date Received10/30/2009
Decision Date 07/06/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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