Alere NT-proBNP for Alinity i
FDA 510(k) clearance K253539 · decided 2026-02-18
Clearance details
- K-number
- K253539
- Device name
- Alere NT-proBNP for Alinity i
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-13
- Decision date
- 2026-02-18
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.