Documento fuente o registro público
FDA 510(k) K211199 — ST AIA-PACK BNP Assay
FDA 510(k) index record K211199. Device: ST AIA-PACK BNP Assay. Applicant as listed: Tosoh Bioscience, Inc.. Decision date: 2021-11-08.
Fuente
"device_name": "ST AIA-PACK BNP 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
2026-10-31
professional use
FDA 510(k) public index record K211199.
Device name: ST AIA-PACK BNP Assay. Applicant as listed: Tosoh Bioscience, Inc..
Decision date: 2021-11-08. Decision wording: Substantially Equivalent.
Product code: NBC. Regulation: 21 CFR 862.1117. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.