VERIFY RESI-TEST SWAB Protein Detection Indicator— 510(k) K260822

Name: FDA 510(k) clearance K260822
Creator: U.S. Food and Drug Administration
Published: 2026-10-28

Substantially Equivalent

Steris

FDA 510(k) clearance K260822 for VERIFY RESI-TEST SWAB Protein Detection Indicator, Substantially Equivalent on 2026-10-28. Applicant: Steris. Device class: 2.

Clearance details

Applicant: Steris
Product code: Product code SDC
Device class: Class 2
Regulation: 21 CFR 880.6930
Advisory panel: General Hospital
Date received: 2026-03-13
Decision date: 2026-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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