Siemens Healthcare Diagnostics Products, Ltd. FDA Approvals

0 new drug approvals and 5 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
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)510(k)Sep 4, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 4, 2026
IMMULITE® 2000 BR-MA510(k)Mar 13, 2024Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Mar 13, 2024
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA510(k)Sep 8, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2023
IMMULITE® 2000 Cortisol510(k)Jan 15, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021
IMMULITE/IMMULITE® 1000 Cortisol510(k)Jan 15, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021