← Product Code [JTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTT) · K855207

# IMIPENEM 10 MCG SENSITIVITY DISCS (K855207)

_Difco Laboratories, Inc. · JTT · Mar 6, 1986 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTT/K855207

## Device Facts

- **Applicant:** Difco Laboratories, Inc.
- **Product Code:** [JTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTT.md)
- **Decision Date:** Mar 6, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Regulatory Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTT/K855207](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTT/K855207)

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