FDA 510(k)

Roche数字病理学Dx（VENTANA DP 200）

K号: K232879 · 2024-06-14

决定日期2024-06-14

产品代码PSY

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决定实质等同

器械摘要

Roche Digital Pathology Dx (VENTANA DP 200) 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 2024-06-14 under 510(k) number K232879. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Roche Digital Pathology Dx (VENTANA DP 200)?

Roche Digital Pathology Dx (VENTANA DP 200) is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K232879.

When did Roche Digital Pathology Dx (VENTANA DP 200) receive FDA 510(k) clearance?

Roche Digital Pathology Dx (VENTANA DP 200) received FDA 510(k) clearance on 2024-06-14, under 510(k) number K232879.

Who is the listed applicant for Roche Digital Pathology Dx (VENTANA DP 200)?

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 Roche Digital Pathology Dx (VENTANA DP 200)?

The FDA product code for Roche Digital Pathology Dx (VENTANA DP 200) is PSY.

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 K212176CINtec 组织学 K172471VENTANA CD30（Ber-H2）RxDx检测

官方来源

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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。