Instrumentation Laboratory (IL) Co. 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
HemosIL Factor V Leiden (APC Resistance V)510(k)Mar 20, 2026Hematology	Hematology	510(k)Substantially Equivalent (Special)	Mar 20, 2026
HemosIL Silica Clotting Time510(k)Jan 9, 2026Hematology	Hematology	510(k)Substantially Equivalent (Special)	Jan 9, 2026
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL510(k)Jul 24, 2025Hematology	Hematology	510(k)Substantially Equivalent (Special)	Jul 24, 2025
HemosIL CL HIT-IgG(PF4-H)510(k)Jan 28, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Jan 28, 2025
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)510(k)Aug 16, 2024Hematology	Hematology	510(k)Substantially Equivalent (Special)	Aug 16, 2024