← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K851561

# WI-38 GENCELLS (K851561)

_Genus Diagnostics · KIR · May 10, 1985 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K851561

## Device Facts

- **Applicant:** Genus Diagnostics
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** May 10, 1985
- **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/K851561](https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K851561)

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