Cleared Special

MetriCide? OPA Plus Solution Test Strip

K241344 · Steris · General Hospital
Jun 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241344 is an FDA 510(k) clearance for the MetriCide? OPA Plus Solution Test Strip, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on June 11, 2024, 29 days after receiving the submission on May 13, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K241344 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date June 11, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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