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) → GJW — Pipette, Pasteur

# GJW · Pipette, Pasteur

_Hematology · 21 CFR 864.6160 · Class 1_

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

## Overview

- **Product Code:** GJW
- **Device Name:** Pipette, Pasteur
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K896670](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GJW/K896670.md) | TIP TOP(R) DISPENSER CAPS | Helena Laboratories | Mar 23, 1990 | SESE |
| [K771138](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GJW/K771138.md) | PIPETS BOROSILICATE GLASS | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| [K771137](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GJW/K771137.md) | PIPETS UNIFORM DROP SIZE BOROSILICATE | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| [K760899](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GJW/K760899.md) | STERILE DISPOSABLE COTTON PLUGGED SER. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 9, 1976 | SESE |

## Top Applicants

- Dade, Baxter Travenol Diagnostics, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Helena Laboratories — 1 clearance

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

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