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 864.9700](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9700) → KSE — Refrigerator, Freezer, Blood Storage

# KSE · Refrigerator, Freezer, Blood Storage

_Hematology · 21 CFR 864.9700 · Class 2_

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

## Overview

- **Product Code:** KSE
- **Device Name:** Refrigerator, Freezer, Blood Storage
- **Regulation:** [21 CFR 864.9700](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9700)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.

## Classification Rationale

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

## Special Controls

*Classification.* Class II (special 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K884436](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSE/K884436.md) | MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 | Harris Mfg. Co. | Dec 2, 1988 | SESE |
| [K813327](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSE/K813327.md) | SEPCOR TEMPERATURE MONITOR | Separation Science Corp. | Dec 31, 1981 | SESE |
| [K802319](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSE/K802319.md) | HEMOTEMP TM | Marion Laboratories, Inc. | Oct 10, 1980 | SESE |
| [K800667](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSE/K800667.md) | MONITEMP BLOOD PACK TEMP. MONITOR | Liquid Crystal Products, Inc. | Apr 16, 1980 | SESE |

## Top Applicants

- Harris Mfg. Co. — 1 clearance
- Liquid Crystal Products, Inc. — 1 clearance
- Marion Laboratories, Inc. — 1 clearance
- Separation Science Corp. — 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/KSE](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSE)

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