← Product Code [JWY](/productcode/JWY) · K001035

# SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) (K001035)

_Trek Diagnostic Systems, Inc. · JWY · May 23, 2000 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K001035

## Device Facts

- **Applicant:** Trek Diagnostic Systems, Inc.
- **Product Code:** [JWY](/productcode/JWY.md)
- **Decision Date:** May 23, 2000
- **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.

---

**Source:** [https://fda.innolitics.com/device/K001035](https://fda.innolitics.com/device/K001035)

**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