Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6160](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6160) → GHO — Hemocytometer

# GHO · Hemocytometer

_Hematology · 21 CFR 864.6160 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHO

## Overview

- **Product Code:** GHO
- **Device Name:** Hemocytometer
- **Regulation:** [21 CFR 864.6160](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6160)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K871671](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHO/K871671.md) | URINOSCOPY FUNNEL | Portable Medical Laboratories, Inc. | May 20, 1987 | SESE |
| [K770980](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHO/K770980.md) | EMATOLOGY DILUENT RESERVOIR CLOSURE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 11, 1977 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Portable Medical Laboratories, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHO](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHO)

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