Immunalysis Corporation FDA Approvals

0 new drug approvals and 6 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
SEFRIA Hydrocodone Oral Fluid510(k)Sep 11, 2025Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 11, 2025
Quantisal Oral Fluid Collection Device510(k)Nov 21, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Nov 21, 2023
Quantisal II Oral Fluid Collection Device510(k)Jul 28, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 28, 2023
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay510(k)Dec 22, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay510(k)Dec 22, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay510(k)Apr 20, 2021	—	510(k)Substantially Equivalent (Traditional)	Apr 20, 2021