← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K951440

# LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (K951440)

_Viromed Laboratories, Inc. · KIR · May 22, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K951440

## Device Facts

- **Applicant:** Viromed Laboratories, Inc.
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** May 22, 1996
- **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/K951440](https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K951440)

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