Documento fuente o registro público
FDA 510(k) K261039 — i-STAT Crea cartridge with the i-STAT 1 System
FDA 510(k) index record K261039. Device: i-STAT Crea cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2026-06-26.
Fuente
"device_name": "i-STAT Crea cartridge with the i-STAT 1 System"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-22
professional use
FDA 510(k) public index record K261039.
Device name: i-STAT Crea cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc..
Decision date: 2026-06-26. Decision wording: Substantially Equivalent.
Product code: CGL. Regulation: 21 CFR 862.1225. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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