# DiaSorin, Inc.

- Location (FDA's records): Stillwater, MN
- FDA decisions: 97 (1990–2026): 73 510(k) clearances, 1 De Novo grant and 23 original PMA approvals
- Names in FDA's records: DiaSorin, Inc. (90); Diasorin (5); Diasorin S.P.A (2)
- Product codes: LOL (10), LOM (6), MRG (6), LSE (5), SEI (4), JJX (4), LSR (4), LFX (3), LGD (3), LFY (3), CEW (3), DFC (3)
- 510(k) review time since 2016: median 89 days, against 90 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 82 (40 its own); citations of its devices by later devices: 61 (40 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diamedix Corp.: 6 (https://510kreport.com/company/diamedix)
- Incstar Corp.: 6 (https://510kreport.com/company/incstar)
- Zeus Scientific, Inc.: 5 (https://510kreport.com/company/zeus-scientific)
- Boehringer Mannheim Corp.: 3 (https://510kreport.com/company/boehringer-mannheim)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Diagnostic Products Corp.: 2 (https://510kreport.com/company/diagnostic-products)
- Mrl Diagnostics: 2 (https://510kreport.com/company/mrl-diagnostics)
- Bayer Corp.: 2 (https://510kreport.com/company/bayer)

## Firms that cite its devices most
- Abbott Laboratories: 3 (https://510kreport.com/company/abbott-laboratories)
- Biokit, S.A.: 3 (https://510kreport.com/company/biokit)
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Diazyme Laboratories: 2 (https://510kreport.com/company/diazyme-laboratories)
- Fujirebio Diagnostics,Inc.: 2 (https://510kreport.com/company/fujirebio-diagnostics)
- Beckman Coulter, Inc.: 2 (https://510kreport.com/company/beckman-coulter)
- Esa Biosciences, Inc.: 1 (https://510kreport.com/company/esa-biosciences)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K112725: Liaison 25 OH Vitamin D Total Assay (2012), cited by 6
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 (2007), cited by 6
- K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays (2005), cited by 4
- K061247: Diasorin Liaison Treponema Assay (2006), cited by 3
- K033426: Liaison N-Tact PTH (2004), cited by 3
- K040290: Diasorin Liaison CMV Igm/Igg (2005), cited by 3

## Recent decisions
- K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (Jun 4, 2026)
- P250039: LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus (May 7, 2026)
- DEN250032: LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (Dec 23, 2025)
- P220034: LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (Mar 29, 2024)
- K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (Oct 27, 2023)
- K223403: LIAISON Anti-HAV; LIAISON XS (Dec 9, 2022)
- K213858: LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (Jul 26, 2022)
- K213936: LIAISON MeMed BV, LIAISON MeMed BV Control Set (Jul 14, 2022)

Source page: https://510kreport.com/company/diasorin