Spd Swiss Precision Diagnostics GmbH FDA Approvals

0 new drug approvals and 4 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
Clearblue® Early Detection Pregnancy Test510(k)Jan 31, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Jan 31, 2024
Clearblue ® Early Pregnancy Test510(k)Sep 21, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 21, 2022
One Step Pregnancy Test510(k)Mar 10, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 10, 2022
Clearblue® Early Digital Pregnancy Test510(k)Aug 13, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 13, 2021