← Product Code [KZJ](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ) · K845008

# BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (K845008)

_Marion Laboratories, Inc. · KZJ · Mar 5, 1985 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K845008

## Device Facts

- **Applicant:** Marion Laboratories, Inc.
- **Product Code:** [KZJ](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ.md)
- **Decision Date:** Mar 5, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2580
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K845008](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZJ/K845008)

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