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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

VERIFY RESI-TEST SWAB Protein Detection Indicator

FDA 510(k) source

510(k) number
K260822
Applicant
Steris
Decision date
Oct 28, 2026
Date received
Mar 13, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
SDC
Device type
Qualitative Cleaning Process Protein Indicator
Device class
Class II
Regulation
21 CFR 880.6930
Advisory committee
General Hospital
Statement or summary
Summary
Third party
N
Location
Mentor, OH, US