← Product Code [KIS](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS) · K870938

# FETAL BOVINE SERUM (K870938)

_Hyclone Laboratories, Inc. · KIS · Mar 31, 1987 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870938

## Device Facts

- **Applicant:** Hyclone Laboratories, Inc.
- **Product Code:** [KIS](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS.md)
- **Decision Date:** Mar 31, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2800
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Animal and human sera are biological products, obtained from the blood of humans or other animals, that provide the necessary growth-promoting nutrients in a cell culture system.

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870938](https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KIS/K870938)

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