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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 K153544
Device Name cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
IQuum, Inc.
700 Nickerson Road
Marlborough,  MA  01752
Applicant Contact Lingjun Chen
IQuum, Inc.
4300 Hacienda Drive
Pleasanton,  CA  94588
Correspondent Contact David W Gates
Regulation Number866.3980
Classification Product Code
Subsequent Product Codes
Date Received12/11/2015
Decision Date 07/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No