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) → GGX — Pipette, Sahli

# GGX · Pipette, Sahli

_Hematology · 21 CFR 864.6160 · Class 1_

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

## Overview

- **Product Code:** GGX
- **Device Name:** Pipette, Sahli
- **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 |
| --- | --- | --- | --- | --- |
| [K902263](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX/K902263.md) | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION | Trimedyne, Inc. | Jul 23, 1990 | SESE |
| [K894389](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GGX/K894389.md) | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Catachem, Inc. | Oct 12, 1989 | SESE |

## Top Applicants

- Catachem, Inc. — 1 clearance
- Trimedyne, Inc. — 1 clearance

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

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