内毒素活性测定（EAA）
K号: K183176 · 2019-03-12
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决定日期2019-03-12
产品代码NGS
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器械摘要
Endotoxin Activity Assay (EAA) is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2019-03-12 under 510(k) number K183176. The device is classified under product code NGS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Endotoxin Activity Assay (EAA)?
Endotoxin Activity Assay (EAA) is a medical device that received FDA 510(k) clearance on 2019-03-12. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K183176.
When did Endotoxin Activity Assay (EAA) receive FDA 510(k) clearance?
Endotoxin Activity Assay (EAA) received FDA 510(k) clearance on 2019-03-12, under 510(k) number K183176.
Who is the listed applicant for Endotoxin Activity Assay (EAA)?
The FDA 510(k) record lists Spectral Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endotoxin Activity Assay (EAA)?
The FDA product code for Endotoxin Activity Assay (EAA) is NGS.
相关临床试验
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列明Spectral Medical, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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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