FDA 510(k)

賓克斯 io CT/NG 檢測與賓克斯 io CT/NG 系統

K 號：K200533 · 2020-04-27

決定日期2020-04-27

產品代碼QEP

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

binx io CT/NG Assay and binx io CT/NG System is the device name listed in this FDA 510(k) record. The listed applicant is Binx Health, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200533. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the binx io CT/NG Assay and binx io CT/NG System?

binx io CT/NG Assay and binx io CT/NG System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Binx Health, Inc.. The 510(k) number is K200533.

When did binx io CT/NG Assay and binx io CT/NG System receive FDA 510(k) clearance?

binx io CT/NG Assay and binx io CT/NG System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200533.

Who is the listed applicant for binx io CT/NG Assay and binx io CT/NG System?

The FDA 510(k) record lists Binx Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for binx io CT/NG Assay and binx io CT/NG System?

The FDA product code for binx io CT/NG Assay and binx io CT/NG System is QEP.

其他以 Binx Health, Inc. 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。

K191352賓克斯健康 io CT/NG 檢測試劑

相關器械（代碼：QEP）

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。

K260917cobas CT/NG用於cobas 5800/6800/8800系統；cobas TV/MG用於cobas 5800/6800/8800系統Roche Molecular Systems, Inc.K253759cobas liat CT/NG/MG 遺傳子測試Roche Molecular Systems, Inc.K253756cobas liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.K251501維斯比醫療男性性健康檢測Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 遺傳子測試Roche Molecular Systems, Inc.

官方來源

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