← Product Code [KZI](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI) · K873320

# SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD (K873320)

_Lakewood Biochemical Co., Inc. · KZI · Sep 29, 1987 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI/K873320

## Device Facts

- **Applicant:** Lakewood Biochemical Co., Inc.
- **Product Code:** [KZI](/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI.md)
- **Decision Date:** Sep 29, 1987
- **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/K873320](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/KZI/K873320)

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