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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sars-Cov-2 Serology Test
510(k) Number K250768
Device Name Elecsys Anti-SARS-CoV-2
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact Tammy Dean
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact Tammy Dean
Classification Product Code
QVP  
Date Received03/13/2025
Decision Date 06/10/2025
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
Predetermined Change
Control Plan Authorized		 No
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