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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 K121003
Model 05N21
Device Name ABBOTT PLEX-ID FLU ASSAY
Original Applicant
ABBOTT LABORATORIES
1300 east touhy avenue
des plaines,  IL  60018
Original Contact darren clarke
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEP   OQW   OTA  
Date Received04/02/2012
Decision Date 12/21/2012
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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