Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Immunoglobulin G (IgG)510(k)Aug 2, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 2, 2023
ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer510(k)Jul 20, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 20, 2023