K230300
- 510(k) number
- K230300
- Device name
- i-STAT CG8+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc. NJ · US
- Product code
- JFP — Electrode, Ion Specific, Calcium
- Decision date
- 2023-10-27
- Date received
- 2023-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K230300.pdf
Official FDA record: K230300
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.