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FDA 510(k)

ARCHITECT梅毒TP试剂, ARCHITECT梅毒TP校准器, ARCHITECT梅毒TP控制

K 號：K153730 · 2016-06-15

申請人Abbott Laboratories
決定日期2016-06-15
產品代碼LIP
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

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K153730. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is Abbott Laboratories. The 510(k) number is K153730.

When did ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control receive FDA 510(k) clearance?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control received FDA 510(k) clearance on 2016-06-15, under 510(k) number K153730.

Who is the listed applicant for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

The FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is LIP.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Abbott Laboratories 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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相關器械（代碼：LIP）

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。

K241427Access梅毒Beckman Coulter, Inc.K241534VITROS 免疫診斷產品 梅毒試劑組Ortho Clinical DiagnosticsK211302Elecsys 梅毒Roche DiagnosticsK170413BioPlex 2200 梅毒總量及RPR，BioPlex 2200 梅毒總量及RPR 校正組合，BioPlex 2200 梅毒總量及RPR 控制組合Bio-Rad LaboratoriesK160910Elecsys 梅毒Roche DiagnosticsK153145Lumipulse G TP-N 適應性反應卡匣組Fujirebio Diagnostics,Inc.

官方來源

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