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FDA 510(k)

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

K 號：K163462 · 2017-09-21

申請人Radiometer Medical Aps
決定日期2017-09-21
產品代碼JHX
諮詢委員會CH
決定相當於

器材摘要

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.

常見問題

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.

其他以 Radiometer Medical Aps 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170882ABL90 FLEX, ABL90 FLEX PLUSK160153ABL90 FLEX PLUS

相關器械（代碼：JHX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS 免疫診斷產品 CK-MB 製劑包Ortho Clinical Diagnostics

官方來源

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