Medical Device Manufacturer · US , Mchenry , IL

Immunalysis Corporation

50 submissions · 50 cleared · Since 1978
50
Total
50
Cleared
0
Denied

Immunalysis Corporation — FDA 510(k) Submissions

Immunalysis Corporation has submitted 50 FDA 510(k) premarket notifications since 1978, of which 50 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Radioimmunoassay, Cannabinoid(s), Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device, Enzyme Immunoassay, Phencyclidine, Enzyme Immunoassay, Cocaine And Cocaine Metabolites . Use the specialty filter in the sidebar to narrow results.

50 devices
1–25 of 50
SEFRIA? Hydrocodone Oral Fluid
K252520 · DJG Enzyme Immunoassay, Opiates · Toxicology
Sep 2025 31d
Quantisal? Oral Fluid Collection Device
K232898 · PJD Oral Fluid Drugs Of Abuse... · Chemistry
Nov 2023 64d
Quantisal? II Oral Fluid Collection Device
K223781 · PJD Oral Fluid Drugs Of Abuse... · Chemistry
Jul 2023 224d
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2021 380d
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · LAF Gas Chromatography,... · Toxicology
Dec 2021 373d
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · LCM Enzyme Immunoassay,... · Toxicology
Apr 2021 144d
Quantisal Oral Fluid Collection Device
K200801 · PJD Oral Fluid Drugs Of Abuse... · Chemistry
Jul 2020 123d
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397 · QBK Meprobamate Test System · Toxicology
Nov 2019 269d
Quantisal II Oral Fluid Collection Device
K183048 · PJD Oral Fluid Drugs Of Abuse... · Chemistry
Jul 2019 269d
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · LCM Enzyme Immunoassay,... · Toxicology
Jan 2019 269d
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · DIC Alcohol Dehydrogenase,... · Toxicology
Oct 2018 140d
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
K161216 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 2017 411d
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K161714 · DIS Enzyme Immunoassay,... · Toxicology
Oct 2016 115d
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K153693 · LAF Gas Chromatography,... · Toxicology
Mar 2016 86d
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K151771 · JXM Enzyme Immunoassay,... · Toxicology
Jan 2016 189d
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · LCM Enzyme Immunoassay,... · Toxicology
Sep 2015 31d
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · DJR Enzyme Immunoassay,... · Toxicology
Jul 2015 59d
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
K150925 · DIO Enzyme Immunoassay,... · Toxicology
Jun 2015 84d
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
K151203 · LDJ Enzyme Immunoassay,... · Toxicology
Jun 2015 31d
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
K143502 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2015 161d
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
K150275 · DJG Enzyme Immunoassay, Opiates · Toxicology
Mar 2015 33d
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
K141803 · DJG Enzyme Immunoassay, Opiates · Toxicology
Feb 2015 224d
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500 · DKZ Enzyme Immunoassay,... · Toxicology
Feb 2015 58d
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
K141406 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2014 34d
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jan 2014 268d
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