SYSTEM，测试，HER-2/NEU，核酸或血清
PMA编号：P040005 · 2017-04-12
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决定日期2017-04-12
PMA 编号P040005
产品代码MVD
设备分类第3类
医疗专科U
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
器械摘要
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd.. It received FDA 510(k) clearance on 2017-04-12. The device is classified under product code MVD. It was reviewed by the PA advisory panel.
常见问题
What is the SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is a medical device that received FDA 510(k) clearance on 2017-04-12. The listed applicant is Agilent Technologies Singapore (International) Pte , Ltd..
When did SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM receive FDA 510(k) clearance?
The clearance date for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM can be found in the official FDA records.
Who is the listed applicant for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
The FDA 510(k) record lists Agilent Technologies Singapore (International) Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM?
The FDA product code for SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM is MVD.
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官方来源
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