K223755
- 510(k) number
- K223755
- Device name
- i-STAT G cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc. NJ · US
- Product code
- CGA — Glucose Oxidase, Glucose
- Decision date
- 2023-09-11
- Date received
- 2022-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K223755.pdf
Official FDA record: K223755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.