Tina-quant 胱素 C Gen.2
K 號：K161817 · 2016-07-27
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器材摘要
Tina-quant Cystatin C Gen.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K161817. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Tina-quant Cystatin C Gen.2?
Tina-quant Cystatin C Gen.2 is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K161817.
When did Tina-quant Cystatin C Gen.2 receive FDA 510(k) clearance?
Tina-quant Cystatin C Gen.2 received FDA 510(k) clearance on 2016-07-27, under 510(k) number K161817.
Who is the listed applicant for Tina-quant Cystatin C Gen.2?
The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tina-quant Cystatin C Gen.2?
The FDA product code for Tina-quant Cystatin C Gen.2 is NDY.
相關臨床試驗
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其他以 Roche Diagnostics Operations (Rdo) 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。
相關器械（代碼：NDY）
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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