Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9275](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9275) → KSO — Centrifuge, Blood-Bank For In Vitro Diagnostic Use

# KSO · Centrifuge, Blood-Bank For In Vitro Diagnostic Use

_Hematology · 21 CFR 864.9275 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO

## Overview

- **Product Code:** KSO
- **Device Name:** Centrifuge, Blood-Bank For In Vitro Diagnostic Use
- **Regulation:** [21 CFR 864.9275](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9275)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K780281](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO/K780281.md) | IMMUFUGE DISP. LINER | Dade, Baxter Travenol Diagnostics, Inc. | Mar 2, 1978 | SESE |

## Top Applicants

- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO)

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