Immunalysis Corporation
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories8
Latest Approval2025-09-11
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252520 | SEFRIA Hydrocodone Oral Fluid | DJG | 2025-09-11 | View |
| 510(k) | K232898 | Quantisal Oral Fluid Collection Device | PJD | 2023-11-21 | View |
| 510(k) | K223781 | Quantisal II Oral Fluid Collection Device | PJD | 2023-07-28 | View |
| 510(k) | K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | DJG | 2021-12-22 | View |
| 510(k) | K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | LAF | 2021-12-22 | View |
| 510(k) | K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | 2021-04-20 | View |
| 510(k) | K200801 | Quantisal Oral Fluid Collection Device | PJD | 2020-07-28 | View |
| 510(k) | K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | QBK | 2019-11-15 | View |
| 510(k) | K183048 | Quantisal II Oral Fluid Collection Device | PJD | 2019-07-29 | View |
| 510(k) | K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | 2019-01-24 | View |
| 510(k) | K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | DIC | 2018-10-31 | View |
| 510(k) | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | DJG | 2017-06-14 | View |
| 510(k) | K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | DIS | 2016-10-14 | View |
| 510(k) | K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | LAF | 2016-03-18 | View |
| 510(k) | K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | JXM | 2016-01-05 | View |
No matching devices.