ALP IFCC Gen.2
K 號：K171080 · 2017-05-10
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器材摘要
ALP IFCC 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 2017-05-10 under 510(k) number K171080. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ALP IFCC Gen.2?
ALP IFCC Gen.2 is a medical device that received FDA 510(k) clearance on 2017-05-10. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K171080.
When did ALP IFCC Gen.2 receive FDA 510(k) clearance?
ALP IFCC Gen.2 received FDA 510(k) clearance on 2017-05-10, under 510(k) number K171080.
Who is the listed applicant for ALP IFCC 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 ALP IFCC Gen.2?
The FDA product code for ALP IFCC Gen.2 is CJE.
其他以 Roche Diagnostics Operations (Rdo) 為申請人之記錄
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相關器械（代碼：CJE）
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。
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官方來源
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