Tosoh Bioscience, Inc. FDA Approvals

0 new drug approvals and 3 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
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01510(k)Oct 3, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 3, 2025
ST AIA-PACK BNP Assay510(k)Nov 8, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Nov 8, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8510(k)Aug 5, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 5, 2021