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 864.9225](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9225) → KSP — Apparatus, Cell-Freezing And Reagents

# KSP · Apparatus, Cell-Freezing And Reagents

_Hematology · 21 CFR 864.9225 · Class 1_

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

## Overview

- **Product Code:** KSP
- **Device Name:** Apparatus, Cell-Freezing And Reagents
- **Regulation:** [21 CFR 864.9225](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9225)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

## 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 |
| --- | --- | --- | --- | --- |
| [K881465](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP/K881465.md) | CRYOBIOLOGICAL FREEZER | Cryodyne Technologies, Inc. | Apr 21, 1988 | SESE |

## Top Applicants

- Cryodyne Technologies, 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/KSP](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP)

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