LTT · Class II · 21 CFR 866.1640

FDA Product Code LTT: Panels, Test, Susceptibility, Antimicrobial

Under FDA product code LTT, antimicrobial susceptibility test panels are cleared for the determination of minimum inhibitory concentrations in clinical microbiology.

These multi-well panels contain dilution series of multiple antibiotics used in broth microdilution testing to determine the MIC of each antibiotic against a clinical isolate, providing quantitative susceptibility data for antibiotic dosing and stewardship decisions.

LTT devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Beckman Coulter, Inc..

3
Total
3
Cleared
219d
Avg days
2025
Since

List of Panels, Test, Susceptibility, Antimicrobial devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
K243804
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
K250036
Beckman Coulter, Inc.
Microbiology · 219d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
K250084
Beckman Coulter, Inc.
Microbiology · 186d

How to use this database

This page lists all FDA 510(k) submissions for Panels, Test, Susceptibility, Antimicrobial devices (product code LTT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →