Source document or public record
FDA 510(k) K200027 — Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
FDA 510(k) index record K200027. Device: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter. Applicant as listed: Jiangsu Caina Medical Co.,Ltd. Decision date: 2020-09-09.
Source
"device_name": "Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K200027.
Device name: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter. Applicant as listed: Jiangsu Caina Medical Co.,Ltd.
Decision date: 2020-09-09. 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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