PAXgene® 血液DNA管
K号: K231469 · 2023-06-21
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决定日期2023-06-21
产品代码PJE
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
PAXgene® Blood DNA Tube is the device name listed in this FDA 510(k) record. The listed applicant is Preanalytix GmbH. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231469. The device is classified under product code PJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PAXgene® Blood DNA Tube?
PAXgene® Blood DNA Tube is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Preanalytix GmbH. The 510(k) number is K231469.
When did PAXgene® Blood DNA Tube receive FDA 510(k) clearance?
PAXgene® Blood DNA Tube received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231469.
Who is the listed applicant for PAXgene® Blood DNA Tube?
The FDA 510(k) record lists Preanalytix GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PAXgene® Blood DNA Tube?
The FDA product code for PAXgene® Blood DNA Tube is PJE.
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官方来源
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