Healgen URS测试条
K号: K231045 · 2023-06-16
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决定日期2023-06-16
产品代码LJX
咨询委员会HE
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器械摘要
Healgen URS Test Strips is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231045. The device is classified under product code LJX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Healgen URS Test Strips?
Healgen URS Test Strips is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K231045.
When did Healgen URS Test Strips receive FDA 510(k) clearance?
Healgen URS Test Strips received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231045.
Who is the listed applicant for Healgen URS Test Strips?
The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Healgen URS Test Strips?
The FDA product code for Healgen URS Test Strips is LJX.
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列明Healgen Scientific,, LLC为申报人的其他记录
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官方来源
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