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 864.9175](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9175) → KSZ — System, Test, Automated Blood Grouping And Antibody

# KSZ · System, Test, Automated Blood Grouping And Antibody

_Hematology · 21 CFR 864.9175 · Class 2_

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

## Overview

- **Product Code:** KSZ
- **Device Name:** System, Test, Automated Blood Grouping And Antibody
- **Regulation:** [21 CFR 864.9175](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9175)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K810899](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K810899.md) | TECHNICON AUTOGROUPER 16-C SYSTEM | Technicon Instruments Corp. | May 5, 1981 | SESE |
| [K790282](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K790282.md) | ELDONCARD | Nordisk Infuser System | May 4, 1979 | SESE |
| [K771098](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K771098.md) | BLOOD GROUPING SYS., BG-9 | Technicon Instruments Corp. | Aug 4, 1977 | SESE |
| [K770185](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K770185.md) | RH CONTROL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 14, 1977 | SESE |

## Top Applicants

- Technicon Instruments Corp. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Nordisk Infuser System — 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/KSZ](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ)

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