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FDA 510(k)

Liquichek 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 MiniPak

K 號：K163015 · 2017-01-10

申請人Bio-Rad Laboratories
決定日期2017-01-10
產品代碼JJY
諮詢委員會CH
決定相當於

器材摘要

Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak 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 2017-01-10 under 510(k) number K163015. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak?

Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak is a medical device that received FDA 510(k) clearance on 2017-01-10. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K163015.

When did Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak receive FDA 510(k) clearance?

Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak received FDA 510(k) clearance on 2017-01-10, under 510(k) number K163015.

Who is the listed applicant for Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak?

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 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak?

The FDA product code for Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak is JJY.

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K170509BioPlex 2200 ToRC IgM，BioPlex 2200 ToRC IgM校准組合包，BioPlex 2200 ToRC IgM控制組合包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K152679Amplichek I, 負面, Amplichek I, 等級 1, Amplichek I, 等級 2, Amplichek I, 等級 3, Amplichek I, MiniPak

相關器械（代碼：JJY）

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。

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD 癌症標記IIAalto Scientific, Ltd.K153712VK-3驗證套件、VK-4驗證套件、VK-R5驗證套件、VK-R7驗證套件、VK-Crea驗證套件Radiometer America, Inc.

官方來源

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