FDA 510(k)

CardioChek Plus 测试系统；CardioChek Plus 家庭测试系统

K号: K193406 · 2022-02-26

申请人Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

决定日期2022-02-26

产品代码NBW

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。

决定实质等同

器械摘要

CardioChek Plus Test System; CardioChek Plus Home Test System is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2022-02-26 under 510(k) number K193406. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the CardioChek Plus Test System; CardioChek Plus Home Test System?

CardioChek Plus Test System; CardioChek Plus Home Test System is a medical device that received FDA 510(k) clearance on 2022-02-26. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K193406.

When did CardioChek Plus Test System; CardioChek Plus Home Test System receive FDA 510(k) clearance?

CardioChek Plus Test System; CardioChek Plus Home Test System received FDA 510(k) clearance on 2022-02-26, under 510(k) number K193406.

Who is the listed applicant for CardioChek Plus Test System; CardioChek Plus Home Test System?

The FDA 510(k) record lists Polymer Technology Systems, Inc. D/B/A Pts Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioChek Plus Test System; CardioChek Plus Home Test System?

The FDA product code for CardioChek Plus Test System; CardioChek Plus Home Test System is NBW. This falls under the OB/GYN category.

列明Polymer Technology Systems, Inc. D/B/A Pts Diagnostics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。

K182781PTS 专业化学试剂盒 K162282CardioChek Plus测试系统，CardioChek家庭测试系统

相关器械（代码：NBW）

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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