Ammonia II
K 號：K183517 · 2019-02-08
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器材摘要
Ammonia II 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 2019-02-08 under 510(k) number K183517. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ammonia II?
Ammonia II is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K183517.
When did Ammonia II receive FDA 510(k) clearance?
Ammonia II received FDA 510(k) clearance on 2019-02-08, under 510(k) number K183517.
Who is the listed applicant for Ammonia II?
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 Ammonia II?
The FDA product code for Ammonia II is JIF.
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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。
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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