FDA 510(k)

ALPCO 胶原蛋白 chemiluminescence ELISA, ALPCO Easy 粪便提取設備

K 號：K191807 · 2019-10-25

申請人ALPCO

決定日期2019-10-25

產品代碼NXO

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

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is the device name listed in this FDA 510(k) record. The listed applicant is ALPCO. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191807. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is ALPCO. The 510(k) number is K191807.

When did ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device receive FDA 510(k) clearance?

ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191807.

Who is the listed applicant for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

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

What is the FDA product code for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device?

The FDA product code for ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device is NXO.

其他以 ALPCO 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。

K220763ALPCO 胶原蛋白免疫濾光測定法

相關器械（代碼：NXO）

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。

K232057布赫曼fCAL® turbo及CALEX® CapBühlmann Laboratories AG K220763ALPCO 胶原蛋白免疫濾光測定法ALPCO K213858LIAISON 肠蛋白酶，LIAISON Q.S.E.T. 裝置＋DiaSorin, Inc.K191718布爾曼fCAL turbo及CALEX Cap醫療設備規範文本Buhlmann Laboratories AG K191592CalprestNG，EasyCalEurospital S.P.A.K191589Calprest, EasyCalEurospital S.P.A.

官方來源

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