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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Qualitative Cleaning Process Protein Indicator
510(k) Number K260822
Device Name VERIFY RESI-TEST SWAB Protein Detection Indicator
Applicant
Steris
5960 Heisley Rd.
Mentor,  OH  44046
Applicant Contact Anthony Piotrkowski
Correspondent
Steris
5960 Heisley Rd.
Mentor,  OH  44046
Correspondent Contact Anthony Piotrkowski
Classification Product Code
SDC  
Date Received03/13/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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