K244042
- 510(k) number
- K244042
- Device name
- Calcium2
- Applicant
- Abbott Ireland IE
- Product code
- CJY — Azo Dye, Calcium
- Decision date
- 2025-02-10
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K244042.pdf
Official FDA record: K244042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.