FDA 510(k)

CardioChek Plus 測試系統；CardioChek Plus 家用測試系統

K 號：K193406 · 2022-02-26

申請人Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

決定日期2022-02-26

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.

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。

K182781PTS專業化學套件 K162282CardioChek Plus 測試系統，CardioChek 家用測試系統

相關器械（代碼：NBW）

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。

K260545CONTOUR® PLUS BLUE 血糖監測系統；CONTOUR® NEXT GEN 血糖監測系統；CONTOUR® NEXT ONE 血糖監測系統Ascensia Diabetes Care K262116TRUE METRIX 自我監測血糖系統Trividia Health, Inc.K250085On Call® 確保 GK 血糖與酮體監測系統；On Call® 確保同步 GK 血糖與酮體監測系統ACON Laboratories, Inc.K243060TeleRPM Gen2 血糖監測系統Guangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST 血糖監測系統 Max TelBionime Corporation K240640Sejoy 血糖監測系統；Sejoy 先進連接血糖監測系統Sejoy Biomedical Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。