FDA 510(k)

CardioChek Plus测试系统，CardioChek家庭测试系统

K号: K162282 · 2016-12-22

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

决定日期2016-12-22

产品代码CGA

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 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 2016-12-22 under 510(k) number K162282. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

CardioChek Plus Test System, CardioChek Home Test System is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K162282.

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

CardioChek Plus Test System, CardioChek Home Test System received FDA 510(k) clearance on 2016-12-22, under 510(k) number K162282.

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

The FDA product code for CardioChek Plus Test System, CardioChek Home Test System is CGA.

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。

K193406CardioChek Plus 测试系统；CardioChek Plus 家庭测试系统 K182781PTS 专业化学试剂盒

官方来源

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