← Product Code [KIR](/productcode/KIR) · K843579

# ULTRACLONE ECL-01-1100 (K843579)

_Earl-Clay Laboratories, Inc. · KIR · Oct 31, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K843579

## Device Facts

- **Applicant:** Earl-Clay Laboratories, Inc.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** Oct 31, 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/K843579](https://fda.innolitics.com/device/K843579)

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