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 PMA record. The listed applicant is Arj Medical, Inc.. It received FDA Premarket Approval (PMA) on 2026-02-05 under PMA number P170022. The device is classified under FDA product code OZA. It was reviewed by the MI advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of M. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

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

Test, urea adult and pediatric (breath), is a medical device that received FDA Premarket Approval (PMA) on 2026-02-05. The listed applicant is Arj Medical, Inc.. The PMA number is P170022.

When did Test, urea adult and pediatric (breath), receive FDA PMA approval?

Test, urea adult and pediatric (breath), received FDA PMA approval on 2026-02-05, under PMA number P170022.

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

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

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

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.

What FDA device class is Test, urea adult and pediatric (breath),?

Test, urea adult and pediatric (breath), is classified as Class III by the FDA.

Related Devices (Code: OZA)

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.

PMA P100025Test, urea adult and pediatric (breath),Meridian Bioscience, 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.

↑