Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5850](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5850) → GKJ — Spinner, Slide, Automated

# GKJ · Spinner, Slide, Automated

_Hematology · 21 CFR 864.5850 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ

## Overview

- **Product Code:** GKJ
- **Device Name:** Spinner, Slide, Automated
- **Regulation:** [21 CFR 864.5850](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5850)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

## 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854962](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K854962.md) | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | Dec 23, 1985 | SESE |
| [K854121](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K854121.md) | MICRO-MAT SYSTEM | Prevo Micro-Mat System | Oct 31, 1985 | SESE |
| [K831558](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K831558.md) | E-Z PREP | Coulter Electronics, Inc. | Jun 16, 1983 | SESE |
| [K811534](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K811534.md) | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | Aug 18, 1981 | SESE |
| [K771898](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K771898.md) | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | Oct 18, 1977 | SESE |
| [K760007](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ/K760007.md) | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | Sep 3, 1976 | SESE |

## Top Applicants

- Geometric Data, Div. Smithkline Corp. — 2 clearances
- Coulter Electronics, Inc. — 1 clearance
- Dynatech Cryomedical Co. — 1 clearance
- Prevo Micro-Mat System — 1 clearance
- Ulster Scientific, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKJ)

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