← Product Code [LTW](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTW) · K853772

# PRECEPT METHICILLIN (K853772)

_Austin Biological Laboratories · LTW · Sep 16, 1985 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTW/K853772

## Device Facts

- **Applicant:** Austin Biological Laboratories
- **Product Code:** [LTW](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTW.md)
- **Decision Date:** Sep 16, 1985
- **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/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTW/K853772](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTW/K853772)

**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