Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

50 results for "Immunalysis Corporation"
1–24 of 50
Cleared Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
K252520 · DJG
Immunalysis Corporation
Toxicology · 31d
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898 · PJD
Immunalysis Corporation
Chemistry · 64d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781 · PJD
Immunalysis Corporation
Chemistry · 224d
Cleared Dec 22, 2021
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · LAF
Immunalysis Corporation
Toxicology · 373d
Cleared Dec 22, 2021
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
K203564 · DJG
Immunalysis Corporation
Toxicology · 380d
Cleared Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · LCM
Immunalysis Corporation
Toxicology · 144d
Cleared Jul 28, 2020
Quantisal Oral Fluid Collection Device
K200801 · PJD
Immunalysis Corporation
Chemistry · 123d
Cleared Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397 · QBK
Immunalysis Corporation
Toxicology · 269d
Cleared Jul 29, 2019
Quantisal II Oral Fluid Collection Device
K183048 · PJD
Immunalysis Corporation
Chemistry · 269d
Cleared Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · LCM
Immunalysis Corporation
Toxicology · 269d
Cleared Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · DIC
Immunalysis Corporation
Toxicology · 140d
Cleared Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl...
K161216 · DJG
Immunalysis Corporation
Toxicology · 411d
Cleared Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K161714 · DIS
Immunalysis Corporation
Toxicology · 115d
Cleared Mar 18, 2016
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K153693 · LAF
Immunalysis Corporation
Toxicology · 86d
Cleared Jan 05, 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K151771 · JXM
Immunalysis Corporation
Toxicology · 189d
Cleared Sep 04, 2015
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · LCM
Immunalysis Corporation
Toxicology · 31d
Cleared Jul 24, 2015
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine...
K151395 · DJR
Immunalysis Corporation
Toxicology · 59d
Cleared Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis...
K150925 · DIO
Immunalysis Corporation
Toxicology · 84d
Cleared Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine...
K151203 · LDJ
Immunalysis Corporation
Toxicology · 31d
Cleared May 20, 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine...
K143502 · DJG
Immunalysis Corporation
Toxicology · 161d
Cleared Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis...
K150275 · DJG
Immunalysis Corporation
Toxicology · 33d
Cleared Feb 12, 2015
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
K141803 · DJG
Immunalysis Corporation
Toxicology · 224d
Cleared Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine...
K143500 · DKZ
Immunalysis Corporation
Toxicology · 58d
Cleared Jul 01, 2014
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE...
K141406 · DJG
Immunalysis Corporation
Toxicology · 34d