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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
Applicant
ABBOT LABORATORIES
1300 east touhy avenue
des plaines,  IL  60018
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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