FDA 510(k)

ipsogen JAK2 RGQ PCR 套件

K 號：K172287 · 2018-01-12

決定日期2018-01-12

產品代碼PSU

諮詢委員會MG (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

ipsogen JAK2 RGQ PCR Kit is the device name listed in this FDA 510(k) record. The listed applicant is Qiagen, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K172287. The device is classified under product code PSU. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ipsogen JAK2 RGQ PCR Kit?

ipsogen JAK2 RGQ PCR Kit is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Qiagen, Inc.. The 510(k) number is K172287.

When did ipsogen JAK2 RGQ PCR Kit receive FDA 510(k) clearance?

ipsogen JAK2 RGQ PCR Kit received FDA 510(k) clearance on 2018-01-12, under 510(k) number K172287.

Who is the listed applicant for ipsogen JAK2 RGQ PCR Kit?

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

What is the FDA product code for ipsogen JAK2 RGQ PCR Kit?

The FDA product code for ipsogen JAK2 RGQ PCR Kit is PSU.

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