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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
Device Name LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
Applicant
IQUUM INC
700 NICKERSON ROAD
MARLBOROUGH,  MA  01762 -4663
Applicant Contact Lingjun Chen
Correspondent
IQUUM INC
700 NICKERSON ROAD
MARLBOROUGH,  MA  01762 -4663
Correspondent Contact Lingjun Chen
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received05/17/2011
Decision Date 08/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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