← Product Code [KSN](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSN) · K790767

# IMMU-TEK AUTOMATIC CENTRIFUGE (K790767)

_Dade, Baxter Travenol Diagnostics, Inc. · KSN · May 23, 1979 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSN/K790767

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [KSN](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSN.md)
- **Decision Date:** May 23, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9285
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro 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/KSN/K790767](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSN/K790767)

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