FDA 510(k)

CalSet IGF-1

K 號：K170938 · 2017-04-26

決定日期2017-04-26

產品代碼JIT

諮詢委員會CH

決定相當於

器材摘要

CalSet IGF-1 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170938. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CalSet IGF-1?

CalSet IGF-1 is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Roche Diagnostics. The 510(k) number is K170938.

When did CalSet IGF-1 receive FDA 510(k) clearance?

CalSet IGF-1 received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170938.

Who is the listed applicant for CalSet IGF-1?

FDA 510(k) 記錄將羅氏醫學診斷列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CalSet IGF-1?

The FDA product code for CalSet IGF-1 is JIT.

其他以 Roche Diagnostics 為申請人之記錄

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K261686Elecsys 磷酸鐵蛋白-Tau (217P) 血漿 K252323cobas pulse 血糖監測系統 K252280Elecsys Anti-SARS-CoV-2 S 醫療設備規範文本 Elecsys Anti-SARS-CoV-2 S 醫療設備，已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的NCT編號為[識別號]，PMID編號為[識別號]。請參考以下URL獲取更多資訊：[URL]。K260048Elecsys 抗-HAV IgM K260049Elecsys 抗-HBc IgM K260046Elecsys 抗-HBc II

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相關器械（代碼：JIT）

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。

K171168維特羅斯免疫診斷產品胰島素校准器Ortho Clinical Diagnostics K170160Abbott ARCHITECT Free T3Abbott Laboratories K163546Lumipulse G 孕酮-N 校准器Fujirebio Diagnostics,Inc.K163534Lumipulse G FSH-N 校正器Fujirebio Diagnostics,Inc.K163544Lumipulse G 乳糖素Fujirebio Diagnostics,Inc.K163521Lumipulse G LH 校准器Fujirebio Diagnostics,Inc.

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