← Product Code [KIR](/productcode/KIR) · K832947

# ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO (K832947)

_Ortho Diagnostic Systems, Inc. · KIR · Sep 29, 1983 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K832947

## Device Facts

- **Applicant:** Ortho Diagnostic Systems, Inc.
- **Product Code:** [KIR](/productcode/KIR.md)
- **Decision Date:** Sep 29, 1983
- **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/K832947](https://fda-staging.innolitics.com/device/K832947)

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