FDA 510(k)

ALPCO 肠钙蛋白化学发光 ELISA, ALPCO 简便粪便提取装置

K号: K191807 · 2019-10-25

申请人ALPCO

决定日期2019-10-25

产品代码NXO

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决定实质等同

器械摘要

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.

常见问题

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.

列明ALPCO为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K220763ALPCO 肠钙蛋白免疫浊度测定

官方来源

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