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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 K252280
Device Name Elecsys Anti-SARS-CoV-2 S
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Applicant Contact Amy Pierce
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46256
Correspondent Contact Alyssa Agana
Classification Product Code
QVP  
Subsequent Product Code
JJX  
Date Received07/22/2025
Decision Date 04/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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