← Product Code [KZI](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI) · K881995

# DIAMOND'S MEDIUM MODIFIED (K881995)

_Remel Co. · KZI · Jun 2, 1988 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI/K881995

## Device Facts

- **Applicant:** Remel Co.
- **Product Code:** [KZI](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI.md)
- **Decision Date:** Jun 2, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2330
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used 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/KZI/K881995](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI/K881995)

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