FDA 510(k)

AQT90 FLEX 肌酸激酶MB（CKMB）测试套件，AQT90 FLEX

K号: K163462 · 2017-09-21

决定日期2017-09-21

产品代码JHX

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决定实质等同

器械摘要

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K163462. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Radiometer Medical Aps. The 510(k) number is K163462.

When did AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX receive FDA 510(k) clearance?

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX received FDA 510(k) clearance on 2017-09-21, under 510(k) number K163462.

Who is the listed applicant for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?

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

What is the FDA product code for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?

The FDA product code for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is JHX.

列明Radiometer Medical Aps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。

K170882ABL90 FLEX，ABL90 FLEX PLUS K160153ABL90 FLEX PLUS

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。

器械摘要

常见问题

列明Radiometer Medical Aps为申报人的其他记录

相关器械（代码：JHX）

官方来源