乙型肝炎病毒B DNA检测
PMA编号：P080026 · 2025-04-18
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决定日期2025-04-18
PMA 编号P080026
产品代码MKT
设备分类第2类
医疗专科M
法规编号21 CFR 8
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器械摘要
Hepatitis Viral B DNA Detection is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2025-04-18. The device is classified under product code MKT. It was reviewed by the MI advisory panel.
常见问题
What is the Hepatitis Viral B DNA Detection?
Hepatitis Viral B DNA Detection is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Abbott Molecular, Inc..
When did Hepatitis Viral B DNA Detection receive FDA 510(k) clearance?
The clearance date for Hepatitis Viral B DNA Detection can be found in the official FDA records.
Who is the listed applicant for Hepatitis Viral B DNA Detection?
The FDA 510(k) record lists Abbott Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hepatitis Viral B DNA Detection?
The FDA product code for Hepatitis Viral B DNA Detection is MKT.
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官方来源
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