Distinct® 早期检测妊娠测试
K号: K193318 · 2020-08-20
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决定日期2020-08-20
产品代码LCX
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
Distinct® Early Detection Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2020-08-20 under 510(k) number K193318. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Distinct® Early Detection Pregnancy Test?
Distinct® Early Detection Pregnancy Test is a medical device that received FDA 510(k) clearance on 2020-08-20. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K193318.
When did Distinct® Early Detection Pregnancy Test receive FDA 510(k) clearance?
Distinct® Early Detection Pregnancy Test received FDA 510(k) clearance on 2020-08-20, under 510(k) number K193318.
Who is the listed applicant for Distinct® Early Detection Pregnancy Test?
The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Distinct® Early Detection Pregnancy Test?
The FDA product code for Distinct® Early Detection Pregnancy Test is LCX.
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列明ACON Laboratories, 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。
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相关器械（代码：LCX）
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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