Immunalysis Corporation - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
Immunalysis Corporation has 50 FDA 510(k) cleared toxicology devices. Based in Mchenry, US.
Latest FDA clearance: Sep 2025. Active since 1978.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Immunalysis Corporation
50 devices
Cleared
Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
Toxicology
31d
Cleared
Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
Chemistry
64d
Cleared
Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
Chemistry
224d
Cleared
Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Toxicology
380d
Cleared
Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
Toxicology
373d
Cleared
Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
Toxicology
144d
Cleared
Jul 28, 2020
Quantisal Oral Fluid Collection Device
Chemistry
123d
Cleared
Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Toxicology
269d
Cleared
Jul 29, 2019
Quantisal II Oral Fluid Collection Device
Chemistry
269d
Cleared
Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
Toxicology
269d
Cleared
Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
Toxicology
140d
Cleared
Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl...
Toxicology
411d
Looking for a specific device from Immunalysis Corporation? Search by device name or K-number.
Search all Immunalysis Corporation devices