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FOX Fastidious Test Panels

by Micro-Media Systems, Inc.

510(k) K953422

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK953422 Date7 Oct 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FOX Fastidious Test Panels are a Manual Antimicrobial Susceptibility Test System designed for in vitro susceptibility testing of bacterial pathogens. These panels provide standardized antimicrobial drug powders in vials, enabling clinical laboratories to evaluate bacterial resistance profiles against therapeutic agents. The system supports microbiological identification and treatment guidance for fastidious organisms, which require specific growth conditions. Its classification as a Class 2 device reflects its role in critical diagnostic workflows within microbiology.

Supplied as single-use antimicrobial susceptibility test panels, these products are intended for use in clinical laboratory settings under controlled conditions. The panels are packaged in sterile vials and must be stored according to manufacturer instructions to maintain efficacy. Compliance with FDA 510(k) clearance (K953422) ensures adherence to regulatory standards for antimicrobial testing systems. Product code JWY identifies this device under the Manual Antimicrobial Susceptibility Test Systems category, governed by regulation 866.1640 for microbiology applications.

Other devices from Micro-Media Systems, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the FOX Fastidious Test Panels used for?

    The FOX Fastidious Test Panels are designed for in vitro susceptibility testing of fastidious bacterial pathogens. These organisms require specific growth conditions, and the panels provide standardized antimicrobial drug powders in vials to evaluate bacterial resistance profiles. This helps guide appropriate treatment decisions in clinical microbiology settings.

  • Are the FOX Fastidious Test Panels single-use or reusable?

    The FOX Fastidious Test Panels are supplied as single-use antimicrobial susceptibility test panels. This design ensures sterility and consistency for each test, reducing the risk of contamination or cross-reactivity between samples.

  • How should the FOX Fastidious Test Panels be stored?

    The panels must be stored according to the manufacturer’s instructions to maintain their efficacy. Proper storage conditions preserve sterility and the integrity of the antimicrobial drug powders, ensuring accurate and reliable test results when used.

  • What regulatory clearance does the FOX Fastidious Test Panels hold?

    The FOX Fastidious Test Panels hold FDA 510(k) clearance under the classification of Manual Antimicrobial Susceptibility Test Systems. This clearance confirms compliance with regulatory standards for antimicrobial testing systems, ensuring their suitability for use in clinical laboratory settings.

  • What product code identifies the FOX Fastidious Test Panels?

    The FOX Fastidious Test Panels are categorized under product code JWY within the Manual Antimicrobial Susceptibility Test Systems classification, governed by FDA regulation 866.1640 for microbiology applications.