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Dried Gram-Negative Gram-Negative MIC/Combo Panels

by Dade Microscan, Inc. 510(k)

Active United States

510(k) K971376

Overview

Dried Gram-Negative MIC/Combo Panels are in vitro diagnostic devices used to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against specific Gram-negative bacteria. They are designed for use with colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

After inoculation, the panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator and can be read either visually or with a MicroScan system. The device is supplied as a dried panel and is intended for single use in clinical microbiology laboratories. It received FDA 510(k) clearance under K971376 and is classified as a Class II device under regulation number 866.1640 with product code JWY.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971376 Date30 May 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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)

Full name
Dried Gram-Negative Mic/Combo Panels
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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