KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
PMA番号：P010007 · 2026-09-22
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決定日2026-09-22
PMA番号P010007
製品コードLOK
デバイスクラスクラス3
診療科U
諮問委員会IM
医療機器の概要
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.
よくある質問
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.
Who is the listed applicant for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?
The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS?
The FDA product code for KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS is LOK.
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公式ソース
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