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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name respiratory virus panel nucleic acid assay system
510(k) Number K110764
Device Name FILMARRAY RP PANEL
Original Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Original Contact beth lingenfelter
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NXD   OEM   OEP   OOI   OOU  
OTG  
Date Received03/21/2011
Decision Date 04/27/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
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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