510(k) K192355

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) by Beckman Coulter, Inc. — Product Code JWY

K192355 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)". The FDA issued a decision of Substantially Equivalent on Nov 14, 2019. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Beckman Coulter, Inc. has 277 other 510(k) clearances on record.