APAS 独立型带尿液分析模块
K号: K183648 · 2019-05-15
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决定日期2019-05-15
产品代码PPU
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器械摘要
APAS Independence with Urine Analysis Module is the device name listed in this FDA 510(k) record. The listed applicant is Clever Culture Systems AG. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K183648. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the APAS Independence with Urine Analysis Module?
APAS Independence with Urine Analysis Module is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Clever Culture Systems AG. The 510(k) number is K183648.
When did APAS Independence with Urine Analysis Module receive FDA 510(k) clearance?
APAS Independence with Urine Analysis Module received FDA 510(k) clearance on 2019-05-15, under 510(k) number K183648.
Who is the listed applicant for APAS Independence with Urine Analysis Module?
The FDA 510(k) record lists Clever Culture Systems AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for APAS Independence with Urine Analysis Module?
The FDA product code for APAS Independence with Urine Analysis Module is PPU.
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相关器械（代码：PPU）
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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