← Product Code [JSL](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSL) · K770650

# PRE-DUCED CULTURE MEDIA (K770650)

_Gibco Laboratories Life Technologies, Inc. · JSL · Apr 15, 1977 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSL/K770650

## Device Facts

- **Applicant:** Gibco Laboratories Life Technologies, Inc.
- **Product Code:** [JSL](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSL.md)
- **Decision Date:** Apr 15, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2390
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSL/K770650](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSL/K770650)

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