FDA 510(k)

皮质醇21-羟化酶抗体（21-OHAb）ELISA试剂盒

K号: K180607 · 2018-11-23

决定日期2018-11-23

产品代码PCG

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决定实质等同

器械摘要

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kronus, Inc.. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K180607. The device is classified under product code PCG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Kronus, Inc.. The 510(k) number is K180607.

When did Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit receive FDA 510(k) clearance?

Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180607.

Who is the listed applicant for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

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

What is the FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit?

The FDA product code for Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit is PCG.

列明Kronus, 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。

K220085KRONUS IA-2自身抗体（IA-2Ab）ELISA试剂盒 K171731KRONUS IA-2自身抗体（IA-2Ab）ELISA试剂盒 K161951KRONUS Aquaporin-4自身抗体（AQP4Ab）ELISA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。

器械摘要

常见问题

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列明Kronus, Inc.为申报人的其他记录

官方来源