DiaSorin, Inc.: FDA filings under this applicant name
FDA lists 71 510(k) clearances under the applicant name “DiaSorin, Inc.” (first 1998, latest 2026), plus 23 PMA and 1 De Novo decisions, across 43 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 89 days, against 133 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 76 |
| 2013 | 10 | 84 |
| 2014 | 2 | 138 |
| 2015 | 2 | 54 |
| 2016 | 4 | 60 |
| 2017 | 3 | 73 |
| 2018 | 3 | 88 |
| 2019 | 2 | 76 |
| 2020 | 4 | 94 |
| 2021 | 4 | 167 |
| 2022 | 3 | 210 |
| 2023 | 1 | 182 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 87 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DiaSorin, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOL | Hepatitis A Test (Antibody And Igm Antibody) | 10 | 8 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 6 | 1 |
| MRG | System, Test, Vitamin D | 6 | 6 |
| LSE | Epstein-Barr Virus, Other | 5 | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| SEI | Qualitative And Quantitative Hepatitis B Virus Antibody Assays | 4 | 0 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 | 3 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 3 | 3 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 | 3 |
Plus 33 more product codes.
Review panels
- Microbiology (57)
- Clinical Chemistry (25)
- Immunology (7)
- Clinical Toxicology (2)
Most recent DiaSorin, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | LOM | 2026-06-04 | 87 |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | LFY | 2023-10-27 | 182 |
| K223403 | LIAISON Anti-HAV; LIAISON XS | LOL | 2022-12-09 | 30 |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | NXO | 2022-07-26 | 228 |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | QPS | 2022-07-14 | 210 |
| K193650 | LIAISON Ferritin | DBF | 2021-09-14 | 624 |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | LSR | 2021-02-18 | 167 |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | LSR | 2021-02-18 | 167 |
| K210272 | LIAISON Anti-HAV | LOL | 2021-02-09 | 8 |
| K201908 | LIAISON Testosterone xt | CDZ | 2020-10-15 | 98 |
61 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250039 | PMA | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | 2026-05-07 |
| DEN250032 | De Novo | Device To Detect Antibodies To Hepatitis D Virus | 2025-12-23 |
| P220034 | PMA | LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus | 2024-03-29 |
| P180048 | PMA | LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg | 2020-08-29 |
| P180049 | PMA | LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe | 2020-08-29 |
Recalls
39 product recalls in 39 recall events; 2 initiated in the last five years. Most recent: 2024-11-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Diasorin Molecular, LLC (13 510(k)s)
- Diasorin S.P.A (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under DiaSorin, Inc.?
FDA lists 71 510(k) clearances under the applicant name “DiaSorin, Inc.” (first 1998, latest 2026), plus 23 PMA and 1 De Novo decisions, across 43 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by DiaSorin, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name DiaSorin, Inc. is 90 days. Since 2017: 89 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DiaSorin, Inc.?
The most frequent FDA product codes under this applicant name are LOL (Hepatitis A Test (Antibody And Igm Antibody), 10); LOM (Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), 6); MRG (System, Test, Vitamin D, 6).
Next steps
- See all 71 DiaSorin, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOL, DiaSorin, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.