Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart I — Hematology Reagents](/submissions/HE/subpart-i%E2%80%94hematology-reagents) → [21 CFR 864.8200](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8200) → GJN — Fluid, Diluting, Red-Cell

# GJN · Fluid, Diluting, Red-Cell

_Hematology · 21 CFR 864.8200 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GJN

## Overview

- **Product Code:** GJN
- **Device Name:** Fluid, Diluting, Red-Cell
- **Regulation:** [21 CFR 864.8200](/submissions/HE/subpart-i%E2%80%94hematology-reagents/864.8200)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

## Classification Rationale

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GJN](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GJN)

**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