测试，成人及儿童尿素（呼吸）
PMA编号：P100025 · 2020-05-26
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决定日期2020-05-26
PMA 编号P100025
产品代码OZA
设备分类第3类
医疗专科M
法规编号21 CFR 8
咨询委员会抱歉，您提供的内容“MI”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。
器械摘要
Test, urea adult and pediatric (breath), is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2020-05-26. The device is classified under product code OZA. It was reviewed by the MI advisory panel.
常见问题
What is the Test, urea adult and pediatric (breath),?
Test, urea adult and pediatric (breath), is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Meridian Bioscience, Inc..
When did Test, urea adult and pediatric (breath), receive FDA 510(k) clearance?
The clearance date for Test, urea adult and pediatric (breath), can be found in the official FDA records.
Who is the listed applicant for Test, urea adult and pediatric (breath),?
The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Test, urea adult and pediatric (breath),?
The FDA product code for Test, urea adult and pediatric (breath), is OZA.
相关临床试验
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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