B R A H M S PCT 敏感 KRYPTOR
K 號：K171338 · 2017-05-31
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器材摘要
B R A H M S PCT sensitive KRYPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Brahms GmbH. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K171338. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the B R A H M S PCT sensitive KRYPTOR?
B R A H M S PCT sensitive KRYPTOR is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Brahms GmbH. The 510(k) number is K171338.
When did B R A H M S PCT sensitive KRYPTOR receive FDA 510(k) clearance?
B R A H M S PCT sensitive KRYPTOR received FDA 510(k) clearance on 2017-05-31, under 510(k) number K171338.
Who is the listed applicant for B R A H M S PCT sensitive KRYPTOR?
The FDA 510(k) record lists Brahms GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for B R A H M S PCT sensitive KRYPTOR?
The FDA product code for B R A H M S PCT sensitive KRYPTOR is PRI.
相關臨床試驗
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相關器械（代碼：PRI）
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。
K220262尺寸 EXL LOCI BRAHMS 前鈣蛋白（PCT）Siemens Healthcare Diagnostics, Inc.K192815Elecsys BRAHMS PCTRoche DiagnosticsK173927Elecsys BRAHMS PCTRoche DiagnosticsK173683LIAISON BRAHMS PCT II GEN，LIAISON Control BRAHMS PCT II GEN，LIAISON BRAHMS PCT II GEN 驗證器DiaSorin, Inc.K172713Lumipulse G B•R•A•H•M•S PCT 免疫反應芯片，Lumipulse G B•R•A•H•M•S PCT 定標器組Fujirebio Diagnostics,Inc.K170652ARCHITECT B.R.A.H.M.S PCT，ARCHITECT B.R.A.H.M.S PCT 校准劑，ARCHITECT B.R.A.H.M.S PCT 控制劑Fisher Diagnostics
官方來源
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