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

FDA PMA

Test, urea adult and pediatric (breath),

PMA Number: P170022 · 2026-02-05

ApplicantArj Medical, Inc.
Decision Date2026-02-05
PMA NumberP170022
Product CodeOZA
Device ClassClass 3
Medical SpecialtyM
Regulation Number21 CFR 8
Advisory CommitteeMI

Device Summary

Test, urea adult and pediatric (breath), is the device name listed in this FDA 510(k) record. The listed applicant is Arj Medical, Inc.. It received FDA 510(k) clearance on 2026-02-05. The device is classified under product code OZA. It was reviewed by the MI advisory panel.

Frequently Asked Questions

What is the Test, urea adult and pediatric (breath),?

Test, urea adult and pediatric (breath), is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Arj Medical, Inc..

When did Test, urea adult and pediatric (breath), receive FDA 510(k) clearance?

The clearance date for Test, urea adult and pediatric (breath), can be found in the official FDA records.

Who is the listed applicant for Test, urea adult and pediatric (breath),?

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

What is the FDA product code for Test, urea adult and pediatric (breath),?

The FDA product code for Test, urea adult and pediatric (breath), is OZA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

↑