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) → JCG — Fluid, Diluting, Manual Cell

# JCG · Fluid, Diluting, Manual Cell

_Hematology · 21 CFR 864.8200 · Class 1_

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

## Overview

- **Product Code:** JCG
- **Device Name:** Fluid, Diluting, Manual 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K892658](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCG/K892658.md) | SDI PREPAX COUNTAPETTE KIT | Scientific Distributors, Inc. | May 24, 1989 | SESE |

## Top Applicants

- Scientific Distributors, Inc. — 1 clearance

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

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