K230285
- 510(k) number
- K230285
- Device name
- i-STAT CG8+ cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc. NJ · US
- Product code
- CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And B
- Decision date
- 2023-10-27
- Date received
- 2023-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K230285.pdf
Official FDA record: K230285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.