epoc 血尿素氮測試，epoc 總二氧化碳測試
K 號：K171247 · 2018-01-17
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器材摘要
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is the device name listed in this FDA 510(k) record. The listed applicant is Epocal, Inc.. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K171247. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Epocal, Inc.. The 510(k) number is K171247.
When did epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test receive FDA 510(k) clearance?
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test received FDA 510(k) clearance on 2018-01-17, under 510(k) number K171247.
Who is the listed applicant for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
The FDA 510(k) record lists Epocal, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test?
The FDA product code for epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test is CDS.
相關臨床試驗
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其他以 Epocal, 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。
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。
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