Documento fuente o registro público
FDA 510(k) K231031 — ACL TOP Family 70 Series
FDA 510(k) index record K231031. Device: ACL TOP Family 70 Series. Applicant as listed: Instrumentation Laboratory Company. Decision date: 2023-06-21.
Fuente
"device_name": "ACL TOP Family 70 Series"
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 K231031.
Device name: ACL TOP Family 70 Series. Applicant as listed: Instrumentation Laboratory Company.
Decision date: 2023-06-21. Decision wording: Substantially Equivalent.
Product code: GKP. Regulation: 21 CFR 864.5400. 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.
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