Documento fuente o registro público
FDA 510(k) K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k) index record K220282. Device: i-STAT PTplus Cartridge with the i-STAT 1 System. Applicant as listed: Abbott Laboratories. Decision date: 2023-07-14.
Fuente
"device_name": "i-STAT PTplus 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
2026-10-29
professional use
FDA 510(k) public index record K220282.
Device name: i-STAT PTplus Cartridge with the i-STAT 1 System. Applicant as listed: Abbott Laboratories.
Decision date: 2023-07-14. Decision wording: Substantially Equivalent.
Product code: GJS. Regulation: 21 CFR 864.7750. Medical specialty: Hematology.
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.