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Antimicrobial Susceptibility Test Panel

by Alamar Biosciences Laboratory, Inc.

510(k) K922003

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922003 Date19 Aug 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Antimicrobial Suscetibility Test Panel
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, 25 Sep 2026

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

The Antimicrobial Susceptibility Test Panel is a manual antimicrobial susceptibility test system, classified as a device in the medical specialty of Microbiology. It is used for determining in vitro susceptibility of bacterial pathogens to therapeutic agents. The device consists of an antimicrobial drug powder packaged in vials in specified amounts. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial infections.

The Antimicrobial Susceptibility Test Panel is supplied by Alamar Biosciences Laboratory, Inc. and has been cleared under FDA 510K with the clearance number K922003. The device is classified as a class 2 device with the regulation number 866.1640. It is intended for use in clinical laboratories and the test results are used to guide treatment decisions. The device has a product code of JWY and is registered with the FDA.

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Questions

AI-generated answers, 25 Sep 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 Antimicrobial Susceptibility Test Panel used for?

    The Antimicrobial Susceptibility Test Panel is a manual system used in clinical laboratories to determine in vitro susceptibility of bacterial pathogens to therapeutic agents. Test results help clinicians select the appropriate antimicrobial agent for treating bacterial infections.

  • How is the Antimicrobial Susceptibility Test Panel supplied?

    The device consists of antimicrobial drug powder packaged in vials in specified amounts. It is supplied by Alamar Biosciences Laboratory, Inc. and is intended for use in clinical laboratory settings to guide treatment decisions.

  • What is the regulatory status of the Antimicrobial Susceptibility Test Panel?

    The Antimicrobial Susceptibility Test Panel has been cleared under FDA 510K with clearance number K922003. It is classified as a class 2 device with regulation number 866.1640 and product code JWY.

  • Is the Antimicrobial Susceptibility Test Panel reusable or single-use?

    The device description does not specify whether it is reusable or single-use. It is a manual antimicrobial susceptibility test system that requires preparation of antimicrobial drug powder in vials for testing bacterial pathogens.