FDA 510(k)

KRONUS IA-2自身抗体（IA-2Ab）ELISA试剂盒

K号: K220085 · 2023-08-24

决定日期2023-08-24

产品代码OIF

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决定实质等同

器械摘要

KRONUS IA-2 Autoantibody (IA-2Ab) 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 2023-08-24 under 510(k) number K220085. The device is classified under product code OIF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Kronus, Inc.. The 510(k) number is K220085.

When did KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit receive FDA 510(k) clearance?

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit received FDA 510(k) clearance on 2023-08-24, under 510(k) number K220085.

Who is the listed applicant for KRONUS IA-2 Autoantibody (IA-2Ab) 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 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?

The FDA product code for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is OIF.

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。

K180607皮质醇21-羟化酶抗体（21-OHAb）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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