Immunalysis Corporation
Immunalysis Corporation appears in FDA public data with 0 recalls, 50 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 11, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 50
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral Fluid | September 11, 2025 |
| K232898 | Quantisal Oral Fluid Collection Device | November 21, 2023 |
| K223781 | Quantisal II Oral Fluid Collection Device | July 28, 2023 |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | December 22, 2021 |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | December 22, 2021 |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | April 20, 2021 |
| K200801 | Quantisal Oral Fluid Collection Device | July 28, 2020 |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | November 15, 2019 |
| K183048 | Quantisal II Oral Fluid Collection Device | July 29, 2019 |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | January 24, 2019 |
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | October 31, 2018 |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators | June 14, 2017 |
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | October 14, 2016 |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | March 18, 2016 |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | January 5, 2016 |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | September 4, 2015 |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis | July 24, 2015 |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, | June 29, 2015 |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis c | June 5, 2015 |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis | May 20, 2015 |