Immunalysis Corporation: FDA clearances and approvals
Immunalysis Corporation has 50 FDA 510(k) clearances (first 1978, latest 2025), across 22 product codes in 2 review panels. Median 510(k) review time: 76 days. Since 2017 its median was 246 days, against 146 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 151 |
| 2015 | 8 | 58 |
| 2016 | 3 | 115 |
| 2017 | 1 | 411 |
| 2018 | 1 | 140 |
| 2019 | 3 | 269 |
| 2020 | 1 | 123 |
| 2021 | 3 | 373 |
| 2022 | 0 | — |
| 2023 | 2 | 144 |
| 2024 | 0 | — |
| 2025 | 1 | 31 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Immunalysis Corporation's cleared 510(k)s took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 11 | 11 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 7 | 7 |
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | 4 | 4 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 | 3 |
| LCM | Enzyme Immunoassay, Phencyclidine | 3 | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 | 2 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 2 | 2 |
| LCL | Radioimmunoassay, Phencyclidine | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
Plus 12 more product codes.
Review panels
Most recent Immunalysis Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252520 | SEFRIA Hydrocodone Oral Fluid | DJG | 2025-09-11 | 31 |
| K232898 | Quantisal Oral Fluid Collection Device | PJD | 2023-11-21 | 64 |
| K223781 | Quantisal II Oral Fluid Collection Device | PJD | 2023-07-28 | 224 |
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | LAF | 2021-12-22 | 373 |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | DJG | 2021-12-22 | 380 |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | 2021-04-20 | 144 |
| K200801 | Quantisal Oral Fluid Collection Device | PJD | 2020-07-28 | 123 |
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | QBK | 2019-11-15 | 269 |
| K183048 | Quantisal II Oral Fluid Collection Device | PJD | 2019-07-29 | 269 |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | LCM | 2019-01-24 | 269 |
40 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immunalysis Corporation.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Immunalysis Corporation have?
Immunalysis Corporation has 50 FDA 510(k) clearances (first 1978, latest 2025), across 22 product codes in 2 review panels.
How long does FDA take to clear Immunalysis Corporation's 510(k)s?
The median time from FDA receipt to decision across Immunalysis Corporation's cleared 510(k)s is 76 days. Since 2017: 246 days, versus 146 days for all cleared 510(k)s in the same product codes.
What devices does Immunalysis Corporation make?
Its most frequent FDA product codes are DJG (Enzyme Immunoassay, Opiates, 11); LAT (Radioimmunoassay, Cannabinoid(S), 7); PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device, 4).
Has Immunalysis Corporation had device recalls?
openFDA lists no recalls under a recalling firm name matching Immunalysis Corporation. Related entities may recall under other names.
Next steps
- See all 50 Immunalysis Corporation clearances with predicates and recalls
- Run predicate analysis for product code DJG, Immunalysis Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.