FDA 510(k)

VITROS化學產品校准套件3

K 號：K161140 · 2016-05-20

決定日期2016-05-20

產品代碼JIX

諮詢委員會CH

決定相當於

器材摘要

VITROS Chemistry Products Calibrator Kit 3 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 2016-05-20 under 510(k) number K161140. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VITROS Chemistry Products Calibrator Kit 3?

VITROS Chemistry Products Calibrator Kit 3 is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K161140.

When did VITROS Chemistry Products Calibrator Kit 3 receive FDA 510(k) clearance?

VITROS Chemistry Products Calibrator Kit 3 received FDA 510(k) clearance on 2016-05-20, under 510(k) number K161140.

Who is the listed applicant for VITROS Chemistry Products Calibrator Kit 3?

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 Calibrator Kit 3?

The FDA product code for VITROS Chemistry Products Calibrator Kit 3 is JIX.

其他以 Ortho-Clinical Diagnostics, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Ortho-Clinical Diagnostics, Inc. 為申請人之記錄

官方來源