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 864.5240](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5240) → GKH — Apparatus, Automated Blood Cell Diluting

# GKH · Apparatus, Automated Blood Cell Diluting

_Hematology · 21 CFR 864.5240 · Class 1_

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

## Overview

- **Product Code:** GKH
- **Device Name:** Apparatus, Automated Blood Cell Diluting
- **Regulation:** [21 CFR 864.5240](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5240)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K100684](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K100684.md) | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Veridex, LLC | Aug 26, 2010 | SESE |
| [K040077](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K040077.md) | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Immunicon Corp. | Mar 12, 2004 | SESE |
| [K022512](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K022512.md) | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Immunicon Corp. | Sep 30, 2002 | SESE |
| [K021150](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K021150.md) | COULTER CELLPREP | Beckman Coulter, Inc. | Jun 11, 2002 | SESE |
| [K935953](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K935953.md) | COULTER MULTI Q PREP | Coulter Corp. | Mar 11, 1994 | SESE |
| [K923530](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K923530.md) | COULTER MULTI-Q-PREP | Coulter Electronics, Inc. | Oct 14, 1992 | SESE |
| [K904795](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K904795.md) | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 31, 1990 | SESE |
| [K882767](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K882767.md) | SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM | Toa Medical Electronics USA, Inc. | Jul 18, 1988 | SESE |
| [K852373](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K852373.md) | AD150, AUTOMATED HEMATOLOGY DILUTOR | Abbott Diagnostics | Jul 5, 1985 | SESE |
| [K842747](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K842747.md) | HYCEL DILUTOR, VARIOUS MODELS/MULTI | R&D Systems, Inc. | Oct 1, 1984 | SESE |
| [K842446](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K842446.md) | DILU-MATIC 140 | Abbott Diagnostics | Sep 6, 1984 | SESE |
| [K823522](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K823522.md) | DILULAB 230 | Innovative Medical Systems, Inc. | Dec 28, 1982 | SESE |
| [K791644](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K791644.md) | ROYCO MODEL 371 SUPER DILUTOR | Royco Instruments | Sep 19, 1979 | SESE |
| [K761137](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKH/K761137.md) | MICROSAMPLE BLOOD COLLECTION DEVICE | Ortho Diagnostics, Inc. | Feb 7, 1977 | SESE |

## Top Applicants

- Abbott Diagnostics — 2 clearances
- Immunicon Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Beckman Coulter, Inc. — 1 clearance
- Coulter Corp. — 1 clearance

---

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

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