APAS Independence 內建尿檢模組
K 號：K183648 · 2019-05-15
廣告
器材摘要
APAS Independence with Urine Analysis Module is the device name listed in this FDA 510(k) record. The listed applicant is Clever Culture Systems AG. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K183648. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the APAS Independence with Urine Analysis Module?
APAS Independence with Urine Analysis Module is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is Clever Culture Systems AG. The 510(k) number is K183648.
When did APAS Independence with Urine Analysis Module receive FDA 510(k) clearance?
APAS Independence with Urine Analysis Module received FDA 510(k) clearance on 2019-05-15, under 510(k) number K183648.
Who is the listed applicant for APAS Independence with Urine Analysis Module?
The FDA 510(k) record lists Clever Culture Systems AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for APAS Independence with Urine Analysis Module?
The FDA product code for APAS Independence with Urine Analysis Module is PPU.
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。
相關器械（代碼：PPU）
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。
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。
廣告