FDA 510(k) Applications for Medical Device Product Code "QLU"

FDA 510(k) Number Applicant Device Name Decision Date
DEN190032 Instrumentation Laboratory Co. HemosIL Liquid Anti-Xa 09/17/2020
K223187 Instrumentation Laboratory Co. HemosIL Liquid Anti-Xa 06/23/2023
K240315 Siemens Healthcare Diagnostics Products GmbH INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) 10/10/2024


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact