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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clinical sample concentrator
510(k) Number K113731
Model ESENSOR XT-8
Device Name ESENSOR RESPIRATORY VIRAL PANEL
Original Applicant
CLINICAL MICRO SENSORS, INC.
5964 la place court
carlsbad,  CA  92008
Original Contact joel centeno
Regulation Number862.2310
Classification Product Code
JJH  
Subsequent Product Codes
NSU   OCC   OEM   OEP   OOU  
OQW   OUL  
Date Received12/19/2011
Decision Date 09/10/2012
Decision substantially equivalent - CLIA submission (CS)
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
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