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Dried Gram-Positive Mic/Combo Panels

by Dade Behring, Inc. 510(k)

Active United States

510(k) K051202

Overview

The Dried Gram-Positive Mic/Combo Panels are Manual Antimicrobial Susceptibility Test Systems, used to determine antimicrobial agent susceptibility. They are classified as a device class 2, under the medical specialty of Microbiology. The panels are designed to test the susceptibility of gram-positive microorganisms to various antimicrobial agents.

The Dried Gram-Positive Mic/Combo Panels are supplied with a product code of JWY and have been cleared under the FDA 510K clearance, with the k number K051202. The device is registered with the FDA and has a regulation number of 866.1640. The panels are used in microbiology settings and are designed to provide accurate and reliable results for antimicrobial susceptibility testing.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051202 Date23 Jun 2005ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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

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Questions

  • What is the Dried Gram-Positive Mic/Combo Panels used for?

    The Dried Gram-Positive Mic/Combo Panels are used to determine antimicrobial agent susceptibility of gram-positive microorganisms in microbiology settings.

  • How are the Dried Gram-Positive Mic/Combo Panels supplied?

    The panels are supplied with a product code of JWY and are designed to provide accurate and reliable results for antimicrobial susceptibility testing.

  • What is the regulatory status of the Dried Gram-Positive Mic/Combo Panels?

    The device has been cleared under the FDA 510K clearance with the k number K051202 and is registered with the FDA with a regulation number of 866.1640.