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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K141338
Device Name LIAT STREP A ASSAY
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 Number866.2680
Classification Product Code
PGX  
Date Received05/21/2014
Decision Date 11/04/2014
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
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