FDA 510(k)

CINtec 组织学

K号: K212176 · 2021-12-10

决定日期2021-12-10

产品代码PRB

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决定实质等同

器械摘要

CINtec Histology is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K212176. The device is classified under product code PRB. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CINtec Histology?

CINtec Histology is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K212176.

When did CINtec Histology receive FDA 510(k) clearance?

CINtec Histology received FDA 510(k) clearance on 2021-12-10, under 510(k) number K212176.

Who is the listed applicant for CINtec Histology?

The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CINtec Histology?

The FDA product code for CINtec Histology is PRB.

列明Ventana Medical Systems, Inc.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。

K242783Roche数字病理学Dx K232879Roche数字病理学Dx（VENTANA DP 200）K172471VENTANA CD30（Ber-H2）RxDx检测

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

列明Ventana Medical Systems, Inc.为申报人的其他记录

官方来源