Medical Device Manufacturer · CN , Suzhou

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. - FDA 510(k) Cl...

2 submissions · 2 cleared · Since 2023

Recent clearances: Immunoglobulin G (IgG), ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Chemistry ✕

1 devices

1-1 of 1

Cleared Jul 20, 2023

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

Chemistry · 472d