Immunalysis Corporation - FDA 510(k) Cleared Devices
Recent clearances: SEFRIA™ Hydrocodone Oral Fluid, Quantisal™ Oral Fluid Collection Device, Quantisal™ II Oral Fluid Collection Device
50
Total
50
Cleared
0
Denied
FDA 510(k) Regulatory Record - Immunalysis Corporation Toxicology ✕
37 devices
Cleared
Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
Toxicology
31d
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
Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Toxicology
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
Cleared
Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
Toxicology
115d
Cleared
Mar 18, 2016
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
Toxicology
86d
Cleared
Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
Toxicology
189d
Cleared
Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Toxicology
31d
Looking for a specific device from Immunalysis Corporation? Search by device name or K-number.
Search all Immunalysis Corporation devices