← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K935766

# PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (K935766)

_Advanced Clinical Diagnostics · KIR · Jan 24, 1994 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K935766

## Device Facts

- **Applicant:** Advanced Clinical Diagnostics
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** Jan 24, 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.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K935766](https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K935766)

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