← Product Code [JTZ](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ) · K853238

# APL MUELLER HINTON AGAR (K853238)

_Apl Medical Supplies · JTZ · Aug 19, 1985 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K853238

## Device Facts

- **Applicant:** Apl Medical Supplies
- **Product Code:** [JTZ](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ.md)
- **Decision Date:** Aug 19, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1700
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K853238](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K853238)

**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
