← Product Code [KSQ](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ) · K802608

# HEMATIC BLOOD MIXER (K802608)

_Helmer Labs, Inc. · KSQ · Dec 11, 1980 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K802608

## Device Facts

- **Applicant:** Helmer Labs, Inc.
- **Product Code:** [KSQ](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ.md)
- **Decision Date:** Dec 11, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9195
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.

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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/KSQ/K802608](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K802608)

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