← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K933926

# LLCMK2 CULTURE CELLS (K933926)

_Neogenex · KIR · Mar 29, 1994 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K933926

## Device Facts

- **Applicant:** Neogenex
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** Mar 29, 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/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K933926](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K933926)

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