← Product Code [KIR](/productcode/KIR) · K780869

# CELL CULTURE LINES (K780869)

_Bioassay Systems Research Corp. · KIR · Aug 14, 1978 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K780869

## Device Facts

- **Applicant:** Bioassay Systems Research Corp.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** Aug 14, 1978
- **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/K780869](https://fda-staging.innolitics.com/device/K780869)

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