LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
FDA 510(k) clearance K260770 · decided 2026-06-04
Clearance details
- K-number
- K260770
- Device name
- LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-09
- Decision date
- 2026-06-04
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- LOM
- Device class
- 2
- Regulation number
- 866.3172
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.