Instrumentation Laboratory CO FDA Approvals

0 new drug approvals and 7 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
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM510(k)Sep 29, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Sep 29, 2023
HemosIL Liquid Anti-Xa510(k)Jun 23, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Jun 23, 2023
GEM Premier ChemSTAT510(k)Jan 27, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Jan 27, 2023
HemosIL von Willebrand Factor Antigen510(k)Dec 9, 2022Hematology	Hematology	510(k)Substantially Equivalent (Special)	Dec 9, 2022
HemosIL Liquid Anti-Xa510(k)Oct 4, 2022Hematology	Hematology	510(k)Substantially Equivalent (Special)	Oct 4, 2022
HemosIL ReadiPlasTin510(k)Aug 16, 2022Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Aug 16, 2022
GEM Premier 5000510(k)Aug 20, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Aug 20, 2021