FDA 510(k)

ALPCO 肠钙蛋白免疫浊度测定

K号: K220763 · 2023-04-13

申请人ALPCO

决定日期2023-04-13

产品代码NXO

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决定实质等同

器械摘要

ALPCO Calprotectin Immunoturbidimetric Assay is the device name listed in this FDA 510(k) record. The listed applicant is ALPCO. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K220763. 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 Immunoturbidimetric Assay?

ALPCO Calprotectin Immunoturbidimetric Assay is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is ALPCO. The 510(k) number is K220763.

When did ALPCO Calprotectin Immunoturbidimetric Assay receive FDA 510(k) clearance?

ALPCO Calprotectin Immunoturbidimetric Assay received FDA 510(k) clearance on 2023-04-13, under 510(k) number K220763.

Who is the listed applicant for ALPCO Calprotectin Immunoturbidimetric Assay?

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 Immunoturbidimetric Assay?

The FDA product code for ALPCO Calprotectin Immunoturbidimetric Assay 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。

K191807ALPCO 肠钙蛋白化学发光 ELISA, ALPCO 简便粪便提取装置

官方来源

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