Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k) clearance K252206 · decided 2026-01-09
Clearance details
- K-number
- K252206
- Device name
- Nova Allegro UACR Assay, Nova Allegro Analyzer
- Applicant
- Nova Biomedical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-07-14
- Decision date
- 2026-01-09
- Days to decision
- 179 days
- Clearance type
- Dual Track
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.