免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

BioPlex 2200 ToRC IgM，BioPlex 2200 ToRC IgM校准組合包，BioPlex 2200 ToRC IgM控制組合包

K 號：K170509 · 2017-05-19

申請人Bio-Rad Laboratories
決定日期2017-05-19
產品代碼PUQ
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

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K170509. The device is classified under product code PUQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K170509.

When did BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set receive FDA 510(k) clearance?

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set received FDA 510(k) clearance on 2017-05-19, under 510(k) number K170509.

Who is the listed applicant for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

The FDA product code for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is PUQ.

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 Bio-Rad 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。

K183446BioPlex 2200 狸蟲病總量K180577BioPlex 2200 25-OH 腫生素D 套件K170413BioPlex 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K163015Liquichek 癌症標記控制級別 1；Liquichek 癌症標記控制級別 2；Liquichek 癌症標記控制級別 3；Liquichek 癌症標記控制- 三級 MiniPakK152679Amplichek I, 負面, Amplichek I, 等級 1, Amplichek I, 等級 2, Amplichek I, 等級 3, Amplichek I, MiniPak

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑