Her-2、ER、PR IH控制
K 號：K220163 · 2022-08-15
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器材摘要
Her-2, ER, PR IHControls is the device name listed in this FDA 510(k) record. The listed applicant is Boston Cell Standards, Inc.. It received FDA 510(k) clearance on 2022-08-15 under 510(k) number K220163. The device is classified under product code NJW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Her-2, ER, PR IHControls?
Her-2, ER, PR IHControls is a medical device that received FDA 510(k) clearance on 2022-08-15. The listed applicant is Boston Cell Standards, Inc.. The 510(k) number is K220163.
When did Her-2, ER, PR IHControls receive FDA 510(k) clearance?
Her-2, ER, PR IHControls received FDA 510(k) clearance on 2022-08-15, under 510(k) number K220163.
Who is the listed applicant for Her-2, ER, PR IHControls?
The FDA 510(k) record lists Boston Cell Standards, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Her-2, ER, PR IHControls?
The FDA product code for Her-2, ER, PR IHControls is NJW.
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官方來源
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