510(k) K202343

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) by Beckman Coulter, Inc. — Product Code LTT

K202343 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )". The FDA issued a decision of Substantially Equivalent on November 16, 2020. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.