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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 K111387
Model 40-03778, 40-03010
Device Name LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
Original Applicant
IQUUM INC
700 nickerson road
marlborough,  MA  01762 4663
Original Contact lingjun chen
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received05/18/2011
Decision Date 08/04/2011
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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