FDA 510(k)

C-反應蛋白套件，適用於SPAPLUS

K 號：K161982 · 2017-04-05

決定日期2017-04-05

產品代碼DCN

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

C-Reactive Protein Kit for use on SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K161982. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C-Reactive Protein Kit for use on SPAPLUS?

C-Reactive Protein Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is The Binding Site Group. The 510(k) number is K161982.

When did C-Reactive Protein Kit for use on SPAPLUS receive FDA 510(k) clearance?

C-Reactive Protein Kit for use on SPAPLUS received FDA 510(k) clearance on 2017-04-05, under 510(k) number K161982.

Who is the listed applicant for C-Reactive Protein Kit for use on SPAPLUS?

The FDA 510(k) record lists The Binding Site Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-Reactive Protein Kit for use on SPAPLUS?

The FDA product code for C-Reactive Protein Kit for use on SPAPLUS is DCN.

相關器械（代碼：DCN）

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。

K232624CardioPhase® 高敏C反蛋白Siemens Healthcare Diagnostic Products GmbH K221119RCRP Flex 製劑芯Siemens Healthcare Diagnostics, Inc.K192072Tina-quant C-反應蛋白 IVRoche Diagnostics Operations (Rdo)K180099Optilite 高敏感度C反應蛋白套件The Binding Site Group , Ltd.K172868Optilite C-反應蛋白試劑，Optilite C-反應蛋白校准劑，Optilite C-反應蛋白控制劑The Binding Site Group , Ltd.K171498MSD CRP測試套件及MESO SECTOR S 700儀器Meso Scale Diagnostics, LLC

官方來源

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