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

FDA 510(k) Number Submission Date Device Name Applicant
K242022 07/11/2024 Access Toxo IgG Beckman Coulter Inc.
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.
K233480 10/26/2023 Access SHBG Beckman Coulter Inc.
K240469 02/20/2024 Access TPO Antibody Beckman Coulter Inc.
K240987 04/10/2024 Access sTfR Beckman Coulter Inc.
K232164 07/21/2023 Access NT-proBNP 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.
K242095 07/17/2024 Access Toxo IgM II Beckman Coulter Inc.


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