AlloMap心脏分子表达测试
K号: K221640 · 2023-09-13
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申请人Caredx, Inc.
决定日期2023-09-13
产品代码OJQ
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
AlloMap Heart Molecular Expression Testing is the device name listed in this FDA 510(k) record. The listed applicant is Caredx, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K221640. The device is classified under product code OJQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AlloMap Heart Molecular Expression Testing?
AlloMap Heart Molecular Expression Testing is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Caredx, Inc.. The 510(k) number is K221640.
When did AlloMap Heart Molecular Expression Testing receive FDA 510(k) clearance?
AlloMap Heart Molecular Expression Testing received FDA 510(k) clearance on 2023-09-13, under 510(k) number K221640.
Who is the listed applicant for AlloMap Heart Molecular Expression Testing?
The FDA 510(k) record lists Caredx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AlloMap Heart Molecular Expression Testing?
The FDA product code for AlloMap Heart Molecular Expression Testing is OJQ.
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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