FDA 510(k)

FREND 雄激素測試系統

K 號：K153577 · 2016-10-14

決定日期2016-10-14

產品代碼CDZ

諮詢委員會CH

決定相當於

器材摘要

FREND Testosterone Test System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K153577. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FREND Testosterone Test System?

FREND Testosterone Test System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K153577.

When did FREND Testosterone Test System receive FDA 510(k) clearance?

FREND Testosterone Test System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K153577.

Who is the listed applicant for FREND Testosterone Test System?

The FDA 510(k) record lists Nanoentek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREND Testosterone Test System?

The FDA product code for FREND Testosterone Test System is CDZ.

其他以 Nanoentek USA, Inc. 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。

K162378FREND PSA PLUS（試劑芯）K162754FREND 钙質D測試系統 K152422FREND™ 自由T4測試系統

相關器械（代碼：CDZ）

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。

K252728IDS-iSYS 全總壓力測試Immunodiagnostic Systems Limited K240865IDS-iSYS 自由濃度睪固酮Immunodiagnostic Systems Limited K233480Access性激素結合球蛋白Beckman Coulter, Inc.K223405Access睪固酮Beckman Coulter, Inc.K211685Elecsys Testosterone IIRoche Diagnostics K201908LIAISON 雄激素 xtDiaSorin, Inc.

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。