← Product Code [KIR](/productcode/KIR) · K940502

# FRESH FROZEN CELLS (K940502)

_Diagnostic Hybrids, Inc. · KIR · Jun 16, 1994 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K940502

## Device Facts

- **Applicant:** Diagnostic Hybrids, Inc.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** Jun 16, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2280
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

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**Source:** [https://fda-staging.innolitics.com/device/K940502](https://fda-staging.innolitics.com/device/K940502)

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