Calcium2— 510(k) K244042
Substantially EquivalentAbbott Ireland
FDA 510(k) clearance K244042 for Calcium2, Substantially Equivalent on 2025-02-10. Applicant: Abbott Ireland. Device class: 2.
Clearance details
- Applicant
- Abbott Ireland
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lisnamuck, IE
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