Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

50 results for "Immunalysis Corporation"
1–24 of 50
Search insights Median review: 71d Cleared: 100% Top manufacturer: Immunalysis Corporation Lead specialty: Toxicology
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