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FDA 510(k) Applications Submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220977
04/04/2022
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
K221114
04/15/2022
Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
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