Streck, Inc. 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
Cell-Free DNA BCT510(k)Jul 26, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024
MDx-Chex for BCID2510(k)Jan 19, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 19, 2022