LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
FDA 510(k) clearance DEN250032 · decided 2025-12-23
Clearance details
- K-number
- DEN250032
- Device name
- LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- Applicant
- DiaSorin, Inc.
- Decision
- Unknown
- Date received
- 2025-07-30
- Decision date
- 2025-12-23
- Days to decision
- 146 days
- Clearance type
- Direct
- Product code
- SGW
- Device class
- 2
- Regulation number
- 866.3176
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.