← Product Code [KIR](/productcode/KIR) · K871033

# RABBIT KIDNEY CULTURE CELLS (FIRST PASS) (K871033)

_Microscan Div. Baxter Healthcare Corp. · KIR · Mar 31, 1987 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K871033

## Device Facts

- **Applicant:** Microscan Div. Baxter Healthcare Corp.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** Mar 31, 1987
- **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/K871033](https://fda-staging.innolitics.com/device/K871033)

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