← Product Code [KSZ](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ) · K771098

# BLOOD GROUPING SYS., BG-9 (K771098)

_Technicon Instruments Corp. · KSZ · Aug 4, 1977 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K771098

## Device Facts

- **Applicant:** Technicon Instruments Corp.
- **Product Code:** [KSZ](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ.md)
- **Decision Date:** Aug 4, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9175
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

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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/K771098](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSZ/K771098)

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