Documento fuente o registro público
FDA 510(k) K220763 — ALPCO Calprotectin Immunoturbidimetric Assay
FDA 510(k) index record K220763. Device: ALPCO Calprotectin Immunoturbidimetric Assay. Applicant as listed: ALPCO. Decision date: 2023-04-13.
Fuente
"device_name": "ALPCO Calprotectin Immunoturbidimetric Assay"
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 K220763.
Device name: ALPCO Calprotectin Immunoturbidimetric Assay. Applicant as listed: ALPCO.
Decision date: 2023-04-13. Decision wording: Substantially Equivalent.
Product code: NXO. Regulation: 21 CFR 866.5180. Medical specialty: Immunology.
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.
