Cleared Traditional

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 ?g/mL)

K250084 · Beckman Coulter, Inc. · Microbiology
Jul 2025
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K250084 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 ?g/mL), a Panels, Test, Susceptibility, Antimicrobial (Class II — Special Controls, product code LTT), submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 18, 2025, 186 days after receiving the submission on January 13, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K250084 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2025
Decision Date July 18, 2025
Days to Decision 186 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LTT — Panels, Test, Susceptibility, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

Similar Devices — LTT Panels, Test, Susceptibility, Antimicrobial

All 49
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 ?g/mL) (MicroScan)
K243804 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 ?g/mL)
K250036 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ?g/mL )
K202343 · Beckman Coulter, Inc. · Nov 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/mL)
K201423 · Beckman Coulter, Inc. · Jun 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8?g/mL)
K193536 · Beckman Coulter, Inc. · Mar 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
K193358 · Beckman Coulter, Inc. · Mar 2020