← Product Code [KIP](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP) · K820928

# EBS POWDER (K820928)

_Dutchland Laboratories, Inc. · KIP · Apr 21, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820928

## Device Facts

- **Applicant:** Dutchland Laboratories, Inc.
- **Product Code:** [KIP](/submissions/HE/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP.md)
- **Decision Date:** Apr 21, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.2875
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820928](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94cell-and-tissue-culture-products/KIP/K820928)

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