FDA applicant
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
FDA records 2 decisions for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (Suzhou, CN) in 2023: 2 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). Its devices cite 2 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Beckman Coulter Laboratory Systems…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Beckman”
FDA records each applicant name separately; these may or may not be the same firm.