FDA 510(k)

VITROS 化学产品 PHBR 胶片

K号: K210858 · 2021-08-13

决定日期2021-08-13

产品代码DLZ

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决定实质等同

器械摘要

VITROS Chemistry Products PHBR Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K210858. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Chemistry Products PHBR Slides?

VITROS Chemistry Products PHBR Slides is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K210858.

When did VITROS Chemistry Products PHBR Slides receive FDA 510(k) clearance?

VITROS Chemistry Products PHBR Slides received FDA 510(k) clearance on 2021-08-13, under 510(k) number K210858.

Who is the listed applicant for VITROS Chemistry Products PHBR Slides?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Chemistry Products PHBR Slides?

The FDA product code for VITROS Chemistry Products PHBR Slides is DLZ.

列明Ortho-Clinical Diagnostics, 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。

K252393VITROS 免疫诊断产品 hs 肌酸激酶同工酶I试剂套装 K191316VITROS XT 化学产品 ALB-TP 薄膜 K190807VITROS XT 化学产品 TBIL-ALKP 试纸 K190520VITROS XT 化学产品 GLU-Ca 试纸 K190490VITROS XT 化学产品 TRIG-CHOL 试纸 K190326VITROS XT 化学产品尿素-肌酐试纸

查看所有 11 个设备 →

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。

器械摘要

常见问题

相关临床试验

列明Ortho-Clinical Diagnostics, Inc.为申报人的其他记录

官方来源