FDA 510(k)

Access 酶解素

K号: K232904 · 2024-04-15

决定日期2024-04-15

产品代码CIN

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Access Ostase is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K232904. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access Ostase?

Access Ostase is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Beckman Coulter. The 510(k) number is K232904.

When did Access Ostase receive FDA 510(k) clearance?

Access Ostase received FDA 510(k) clearance on 2024-04-15, under 510(k) number K232904.

Who is the listed applicant for Access Ostase?

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

What is the FDA product code for Access Ostase?

The FDA product code for Access Ostase is CIN.

列明Beckman Coulter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。

K193124Unicel DxH 800 Coulter 细胞分析系统 K182886Cytomics FC 500系列（MPL或MCL）流式细胞仪 K183592ClearLLab 10C 面板（B，T，M1，M2），Navios 流式细胞仪，Navios EX 流式细胞仪 K181599Unicel DxH 800 细胞分析系统及早期脓毒症指示器应用 K181475DxH 520血液分析仪 K162897Navios EX 流式细胞仪，6色/2激光，Navios EX 流式细胞仪，8色/2激光，Navios EX 流式细胞仪，10色/3激光

查看所有 7 个设备 →

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。