← Product Code [KJA](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KJA) · K864021

# TISSUE CULTURE FLASK (K864021)

_Fenwal Laboratories · KJA · Oct 29, 1986 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KJA/K864021

## Device Facts

- **Applicant:** Fenwal Laboratories
- **Product Code:** [KJA](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KJA.md)
- **Decision Date:** Oct 29, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2240
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KJA/K864021](https://fda.innolitics.com/submissions/PA/subpart-c%E2%80%94cell-and-tissue-culture-products/KJA/K864021)

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