Documento fuente o registro público
FDA 510(k) K213146 — Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
FDA 510(k) index record K213146. Device: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen. Applicant as listed: Jiangsu Rongye Technology Co., Ltd.. Decision date: 2023-10-27.
Fuente
"device_name": "Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen"
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
2026-10-28
professional use
FDA 510(k) public index record K213146.
Device name: Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen. Applicant as listed: Jiangsu Rongye Technology Co., Ltd..
Decision date: 2023-10-27. Decision wording: Substantially Equivalent.
Product code: JKA. Regulation: 21 CFR 862.1675. 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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