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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 K260333
Device Name LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
Applicant
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Applicant Contact Kate Goscha
Correspondent
Diasorin Molecular, LLC
11331 Valley View St.
Cypress,  CA  90630
Correspondent Contact Kate Goscha
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received02/02/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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