VERIFY Spore Test Strip for S40 Sterilant Concentrate— 510(k) K231746

Name: FDA 510(k) clearance K231746
Creator: U.S. Food and Drug Administration
Published: 2023-09-11

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K231746 for VERIFY Spore Test Strip for S40 Sterilant Concentrate, Substantially Equivalent on 2023-09-11. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code OVY
Device class: Class 2
Regulation: 21 CFR 880.6887
Advisory panel: General Hospital
Date received: 2023-06-15
Decision date: 2023-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE2023-12-15
K180553 — VERIFY Spore Test Strip for S40 Sterilant2018-05-29
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