← Product Code [KIR](/productcode/KIR) · K841342

# ULTRACLONE ECL-01-400 CELL LINE (K841342)

_Earl-Clay Laboratories, Inc. · KIR · May 11, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K841342

## Device Facts

- **Applicant:** Earl-Clay Laboratories, Inc.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** May 11, 1984
- **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.innolitics.com/device/K841342](https://fda.innolitics.com/device/K841342)

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