← Product Code [KIT](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIT) · K843864

# ULTRACLONE ECL-01-1400 CELL LINE (K843864)

_Earl-Clay Laboratories, Inc. · KIT · Oct 17, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIT/K843864

## Device Facts

- **Applicant:** Earl-Clay Laboratories, Inc.
- **Product Code:** [KIT](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIT.md)
- **Decision Date:** Oct 17, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2220
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Synthetic cell and tissue culture media and components are substances that are composed entirely of defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the survival and development of cell lines of humans and other animals. This does not include tissue culture media for human ex vivo tissue and cell culture processing applications as described in § 876.5885 of this chapter.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIT/K843864](https://fda.innolitics.com/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIT/K843864)

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