JLK, Inc. FDA Approvals

0 new drug approvals and 8 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
JLK-NCCT510(k)Mar 24, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 24, 2026
JLK-SDH510(k)Mar 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 3, 2025
JLK-AILink510(k)Feb 25, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 25, 2025
JLK-ICH510(k)Jan 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 3, 2025
JLK-PWI510(k)Nov 4, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 4, 2024
JLK-CTP510(k)Oct 16, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 16, 2024
JBS-LVO510(k)Sep 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 27, 2024
Medihub Prostate510(k)Jun 21, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2024