Instrumentation Laboratory Company FDA Approvals

0 new drug approvals and 3 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 Chromogenic Factor IX510(k)Dec 13, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2023
GEM Premier 7000 with IQM3510(k)Aug 10, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023
ACL TOP Family 70 Series510(k)Jun 21, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2023