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) → GLG — Platelet Counting, Manual

# GLG · Platelet Counting, Manual

_Hematology · 21 CFR 864.6160 · Class 1_

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

## Overview

- **Product Code:** GLG
- **Device Name:** Platelet Counting, Manual
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K842921](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GLG/K842921.md) | REES & ECKER DILUTION FLUID | E K Ind., Inc. | Sep 7, 1984 | SESE |
| [K811084](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GLG/K811084.md) | LABTRONIX PLATELET COUNTER(L/O/C.) | Labtronix Corp. | Jul 23, 1981 | SESE |
| [K772105](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GLG/K772105.md) | PLATELET KIT | Streck Laboratories, Inc. | Nov 30, 1977 | SESE |

## Top Applicants

- E K Ind., Inc. — 1 clearance
- Labtronix Corp. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance

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

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