← Product Code [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR) · K955921

# A549 CELL CULTURE (K955921)

_Viratest Intl., Inc. · KIR · Feb 16, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K955921

## Device Facts

- **Applicant:** Viratest Intl., Inc.
- **Product Code:** [KIR](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR.md)
- **Decision Date:** Feb 16, 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.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K955921](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIR/K955921)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com