← Product Code [JTZ](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ) · K861301

# BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 (K861301)

_Troy Biologicals, Inc. · JTZ · Apr 21, 1986 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K861301

## Device Facts

- **Applicant:** Troy Biologicals, Inc.
- **Product Code:** [JTZ](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ.md)
- **Decision Date:** Apr 21, 1986
- **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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K861301](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTZ/K861301)

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