BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
3 FDA actions
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
deviceClass II
Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
device
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
device