Calcium2
FDA 510(k) clearance K244042 · decided 2025-02-10
Clearance details
- K-number
- K244042
- Device name
- Calcium2
- Applicant
- Abbott Ireland
- Decision
- Substantially Equivalent
- Date received
- 2024-12-30
- Decision date
- 2025-02-10
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lisnamuck, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.