510(k) K190109

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) by Beckman Coulter, Inc. — Product Code JWY

K190109 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)". The FDA issued a decision of Substantially Equivalent on Apr 18, 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.