# PAR · Test, Volatile Organic Compounds Breath Analysis

_ ·  · Class f_

**Canonical URL:** https://fda.innolitics.com/productcode/PAR

## Overview

- **Product Code:** PAR
- **Device Name:** Test, Volatile Organic Compounds Breath Analysis
- **Regulation:** 21 CFR N/A
- **Device Class:** f
- **Review Panel:** [](/submissions/)

## Identification

Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/productcode/PAR](https://fda.innolitics.com/productcode/PAR)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com