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FDA 510(k)

TriVerity

K-Number: K241676 · 2025-01-10

ApplicantInflammatix, Inc.
Decision Date2025-01-10
Product CodePRE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TriVerity is the device name listed in this FDA 510(k) record. The listed applicant is Inflammatix, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K241676. The device is classified under product code PRE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriVerity?

TriVerity is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Inflammatix, Inc.. The 510(k) number is K241676.

When did TriVerity receive FDA 510(k) clearance?

TriVerity received FDA 510(k) clearance on 2025-01-10, under 510(k) number K241676.

Who is the listed applicant for TriVerity?

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

What is the FDA product code for TriVerity?

The FDA product code for TriVerity is PRE.

Related Devices (Code: PRE)

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.

K232095SeptiCyte RAPIDImmunexpress, Inc.K203748SeptiCyte RAPIDImmunexpress, Inc.K163260SeptiCyte LABImmunexpress, Inc.

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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