← Product Code [JSK](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSK) · K881566

# HEMOGLOBIN POWDER (K881566)

_Acumedia Manufacturers, Inc. · JSK · Apr 18, 1988 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSK/K881566

## Device Facts

- **Applicant:** Acumedia Manufacturers, Inc.
- **Product Code:** [JSK](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSK.md)
- **Decision Date:** Apr 18, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2450
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSK/K881566](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSK/K881566)

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