Cleared Traditional

Ultraphon Chemical Indicator (TRO-T and TRO-B)

K233413 · True Indicating, LLC · General Hospital
Jun 2024
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K233413 is an FDA 510(k) clearance for the Ultraphon Chemical Indicator (TRO-T and TRO-B), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on June 26, 2024, 264 days after receiving the submission on October 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K233413 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2023
Decision Date June 26, 2024
Days to Decision 264 days
Submission Type Traditional
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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