CRC-77tHR
K号: K162394 · 2017-03-08
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器械摘要
CRC-77tHR is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K162394. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the CRC-77tHR?
CRC-77tHR is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Capintec, Inc.. The 510(k) number is K162394.
When did CRC-77tHR receive FDA 510(k) clearance?
CRC-77tHR received FDA 510(k) clearance on 2017-03-08, under 510(k) number K162394.
Who is the listed applicant for CRC-77tHR?
The FDA 510(k) record lists Capintec, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CRC-77tHR?
The FDA product code for CRC-77tHR is KPT. This falls under the In Vitro Diagnostics category.
列明Capintec, 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。
相关器械（代码：KPT）
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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