FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
K Number: DEN250032
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
71
Review Days
146
Basic Information
- Device Name
- LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- K Number
- DEN250032
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3176
- Medical Specialty
- Immunology
- Decision
- Unknown
- Applicant
- DiaSorin, Inc.
- Date Received
- July 30, 2025
- Decision Date
- December 23, 2025
- Product Code
- SGW
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SGW | Device To Detect Antibodies To Hepatitis D Virus | FDA class 2 | Immunology |
Other Clearances by DiaSorin, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | Jun 4, 2026 | Substantially Equivalent |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | Oct 27, 2023 | Substantially Equivalent |
| K223403 | LIAISON Anti-HAV; LIAISON XS | Dec 9, 2022 | Substantially Equivalent |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | Jul 26, 2022 | Substantially Equivalent |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | Jul 14, 2022 | Substantially Equivalent |
| K193650 | LIAISON Ferritin | Sep 14, 2021 | Substantially Equivalent |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | Feb 18, 2021 | Substantially Equivalent |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | Feb 18, 2021 | Substantially Equivalent |
| K210272 | LIAISON Anti-HAV | Feb 9, 2021 | Substantially Equivalent |
| K201908 | LIAISON Testosterone xt | Oct 15, 2020 | Substantially Equivalent |