Cleared Traditional

MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 ?g/mL) (MicroScan)

K243804 · Beckman Coulter, Inc. · Microbiology
Aug 2025
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K243804 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 ?g/mL) (MicroScan), 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 August 20, 2025, 252 days after receiving the submission on December 11, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K243804 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2024
Decision Date August 20, 2025
Days to Decision 252 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-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 Aztreonam (AZT) (0.5-64 ?g/mL)
K250084 · Beckman Coulter, Inc. · Jul 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