CaloPix
FDA 510(k) clearance K250414 · decided 2025-05-14
Clearance details
- K-number
- K250414
- Device name
- CaloPix
- Applicant
- Tribun Health
- Decision
- Substantially Equivalent
- Date received
- 2025-02-13
- Decision date
- 2025-05-14
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QKQ
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.