K240468
- 510(k) number
- K240468
- Device name
- Alkaline Phosphatase
- Applicant
- Abbott Laboratories Diagnostics Division TX · US
- Product code
- CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenz
- Decision date
- 2024-10-16
- Date received
- 2024-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K240468.pdf
Official FDA record: K240468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.