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FDA 510(k)

OSOM單一測試；Sure Vue Signature單一；ImmunoCard STAT單一；Cardinal Health Mono II快速測試

K 號：K181436 · 2018-06-22

申請人SEKISUI Diagnostics, LLC
決定日期2018-06-22
產品代碼KTN
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

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is SEKISUI Diagnostics, LLC. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K181436. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is SEKISUI Diagnostics, LLC. The 510(k) number is K181436.

When did OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test receive FDA 510(k) clearance?

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test received FDA 510(k) clearance on 2018-06-22, under 510(k) number K181436.

Who is the listed applicant for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

The FDA 510(k) record lists SEKISUI Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test?

The FDA product code for OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test is KTN.

相關臨床試驗

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。

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其他以 SEKISUI Diagnostics, LLC 為申請人之記錄

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。

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