Kolplast 宫颈样本收集套装
K号: K153128 · 2017-01-13
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决定日期2017-01-13
产品代码HHT
咨询委员会OB
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决定实质等同
器械摘要
Kolplast Cervical Sample Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kolplast CI SA. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K153128. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Kolplast Cervical Sample Collection Kit?
Kolplast Cervical Sample Collection Kit is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Kolplast CI SA. The 510(k) number is K153128.
When did Kolplast Cervical Sample Collection Kit receive FDA 510(k) clearance?
Kolplast Cervical Sample Collection Kit received FDA 510(k) clearance on 2017-01-13, under 510(k) number K153128.
Who is the listed applicant for Kolplast Cervical Sample Collection Kit?
The FDA 510(k) record lists Kolplast CI SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Kolplast Cervical Sample Collection Kit?
The FDA product code for Kolplast Cervical Sample Collection Kit is HHT.
相关临床试验
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相关器械（代码：HHT）
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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