Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Inflammatix, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval 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. It is manufactured by Inflammatix, Inc.. The 510(k) number is K241676.

When was TriVerity approved by the FDA?

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

What company makes TriVerity?

TriVerity is manufactured by Inflammatix, Inc..

What is the FDA product code for TriVerity?

The FDA product code for TriVerity is PRE.

Related Devices (Code: PRE)

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

↑