← Product Code [KSO](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO) · K780281

# IMMUFUGE DISP. LINER (K780281)

_Dade, Baxter Travenol Diagnostics, Inc. · KSO · Mar 2, 1978 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO/K780281

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [KSO](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO.md)
- **Decision Date:** Mar 2, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9275
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.

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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/KSO/K780281](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSO/K780281)

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