FDA 510(k) Applications Submitted by Beckman Coulter Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K201405 05/28/2020 LabPro Data Management System Beckman Coulter Inc.
K161837 07/05/2016 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer BECKMAN COULTER INC.
K162208 08/05/2016 DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent BECKMAN COULTER INC.
K172912 09/25/2017 MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) Beckman Coulter Inc.


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