Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640) → LOP — Solution, Antimicrobial

# LOP · Solution, Antimicrobial

_Microbiology · 21 CFR 866.1640 · Class 2_

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

## Overview

- **Product Code:** LOP
- **Device Name:** Solution, Antimicrobial
- **Regulation:** [21 CFR 866.1640](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1640)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K902004](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LOP/K902004.md) | TROBICIN SUSCEPTIBILITY POWDER | The Upjohn Co. | May 15, 1990 | SESE |
| [K900455](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LOP/K900455.md) | ZEFAZONE SUSCEPTIBILITY POWDER | The Upjohn Co. | Feb 9, 1990 | SESE |
| [K810471](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LOP/K810471.md) | STOCK ANTIMICROBIC SOLUTIONS | Cathra International, Inc. | Apr 1, 1981 | SESE |

## Top Applicants

- The Upjohn Co. — 2 clearances
- Cathra International, Inc. — 1 clearance

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

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