Ultraphon Chemical Indicator (TRO-T and TRO-B)— 510(k) K233413

Name: FDA 510(k) clearance K233413
Creator: U.S. Food and Drug Administration
Published: 2024-06-26

Substantially Equivalent

True Indicating, LLC

FDA 510(k) clearance K233413 for Ultraphon Chemical Indicator (TRO-T and TRO-B), Substantially Equivalent on 2024-06-26. Applicant: True Indicating, LLC. Device class: 2.

Clearance details

Applicant: True Indicating, LLC
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2023-10-06
Decision date: 2024-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOJ

view all

K263267 — Endox Test Strips2026-10-16
K261992 — 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)2026-09-25
K260181 — LF Process Indicator Tape for Steam Sterilization2026-02-20
K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) +1 more2025-12-23
K251035 — DISINTEK PA Test Strips2025-06-03

More clearances from True Indicating, LLC

view all

K251559 — InstaTRU Instant Biological Indicator for Steam (IBI-05)2026-06-18
K242860 — Type 5 Integrating Indicator for Steam (CSPN-15)2025-01-17
K220778 — Chemical Indicator for Steam2022-12-02
K210481 — Instant 20s Indicator2021-12-14
K200970 — Self-Contained Biological Indicator2020-12-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.