K261039
- 510(k) number
- K261039
- Device name
- i-STAT Crea cartridge with the i-STAT 1 System
- Applicant
- Abbott Point of Care, Inc. NJ · US
- Product code
- CGL — Electrode, Ion Based, Enzymatic, Creatinine
- Decision date
- 2026-06-26
- Date received
- 2026-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K261039.pdf
Official FDA record: K261039
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.