FDA 510(k)

N 人免疫球蛋白（IgG、IgA 及 IgM）抗血清

K 號：K233663 · 2023-12-13

申請人Siemens Healthcare Diagnostics Products GmbH

決定日期2023-12-13

產品代碼CFN

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K233663. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K233663.

When did N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) receive FDA 510(k) clearance?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) received FDA 510(k) clearance on 2023-12-13, under 510(k) number K233663.

Who is the listed applicant for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

The FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is CFN.

其他以 Siemens Healthcare Diagnostics Products GmbH 為申請人之記錄

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相關器械（代碼：CFN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K221114免疫球蛋白G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116人類IgA液態試劑套件，適用於SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA 套件The Binding Site Group , Ltd.K191635Optilite IgM 套件The Binding Site Group , Ltd.K191465人類IgM試劑，適用於SPAPlusThe Binding Site Group , Ltd.K190686Optilite IgM CSF 套件The Binding Site Group , Ltd.

官方來源

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