Viramed Borrela 全合一 ViraChip 检测试剂盒
K号: K220016 · 2022-08-19
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决定日期2022-08-19
产品代码LSR
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器械摘要
Viramed Borrela All-In-One ViraChip Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Viramed Biotech AG. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220016. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Viramed Borrela All-In-One ViraChip Test Kit?
Viramed Borrela All-In-One ViraChip Test Kit is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Viramed Biotech AG. The 510(k) number is K220016.
When did Viramed Borrela All-In-One ViraChip Test Kit receive FDA 510(k) clearance?
Viramed Borrela All-In-One ViraChip Test Kit received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220016.
Who is the listed applicant for Viramed Borrela All-In-One ViraChip Test Kit?
The FDA 510(k) record lists Viramed Biotech AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Viramed Borrela All-In-One ViraChip Test Kit?
The FDA product code for Viramed Borrela All-In-One ViraChip Test Kit is LSR.
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列明Viramed Biotech AG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。
相关器械（代码：LSR）
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。
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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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