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FDA 510(k)

CardioChek Plus 測試系統，CardioChek 家用測試系統

K 號：K162282 · 2016-12-22

申請人Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
決定日期2016-12-22
產品代碼CGA
諮詢委員會CH
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K193406CardioChek Plus 測試系統；CardioChek Plus 家用測試系統K182781PTS專業化學套件

相關器械（代碼：CGA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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