510(k) K172255

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) by Beckman Coulter, Inc. — Product Code LTT

K172255 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)". The FDA issued a decision of Substantially Equivalent on December 1, 2017. 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.