← Product Code [JSG](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSG) · K881564

# TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564)

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

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSG/K881564

## Device Facts

- **Applicant:** Acumedia Manufacturers, Inc.
- **Product Code:** [JSG](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSG.md)
- **Decision Date:** Apr 18, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2300
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

A multipurpose culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes for the cultivation and identification of several types of pathogenic microorganisms without the need of additional nutritional supplements. Test results aid in the diagnosis of disease and also provide epidemiological information on diseases caused by these microorganisms.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSG/K881564](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSG/K881564)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com