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FDA 510(k)

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

K-Number: K233413 · 2024-06-26

ApplicantTrue Indicating, LLC
Decision Date2024-06-26
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ultraphon Chemical Indicator (TRO-T and TRO-B) is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K233413. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraphon Chemical Indicator (TRO-T and TRO-B)?

Ultraphon Chemical Indicator (TRO-T and TRO-B) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is True Indicating, LLC. The 510(k) number is K233413.

When did Ultraphon Chemical Indicator (TRO-T and TRO-B) receive FDA 510(k) clearance?

Ultraphon Chemical Indicator (TRO-T and TRO-B) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233413.

Who is the listed applicant for Ultraphon Chemical Indicator (TRO-T and TRO-B)?

The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultraphon Chemical Indicator (TRO-T and TRO-B)?

The FDA product code for Ultraphon Chemical Indicator (TRO-T and TRO-B) is JOJ.

Other records listing True Indicating, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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