KIT, 神经管缺陷测试
PMA编号：P010007 · 2026-09-22
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决定日期2026-09-22
PMA 编号P010007
产品代码LOK
设备分类第3类
医疗专科U
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器械摘要
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-09-22. The device is classified under product code LOK. It was reviewed by the IM advisory panel.
常见问题
What is the KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Siemens Healthcare Diagnostics, Inc..
When did KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS receive FDA 510(k) clearance?
The clearance date for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS can be found in the official FDA records.
谁是被列为KIT、TEST、用于神经管缺陷的ALPHA-FETOPROTEIN的申请人？
FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。
FDA产品代码是多少，用于KIT、TEST、用于神经管缺陷的ALPHA-FETOPROTEIN？
FDA产品代码为KIT、TEST、ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS的为LOK。
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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