510(k) Premarket Notification | 合法醫療器材資訊網
Applicant:ABBOTTLABORATORIESDecisionDateTo:12/27/2019...16.tdx(r)/tdxflx(r)phenytoinii17,ABBOTTLABORATORIES,K94632818,03/28/1995.
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
ABBOTT TDX/TDXFLX BARBITURATES IIU ABBOTT TDX/TDXFLX BARBITURATES IIU 雅琉恩輸尿管支架組 “Southern”Endosseous Dental Implant Accessories (Non-Sterile) theracal price sterilance lite 3 sterilance lite 2 和豐國際行銷股份有限公司 衛 部 醫器 製 壹 字 第 006232 號 翔緯口罩全家
510(k) Premarket Notification | 合法醫療器材資訊網
Applicant: ABBOTT LABORATORIES Decision Date To: 12/27/2019 ... 16. tdx(r)/tdxflx(r) phenytoin ii17, ABBOTT LABORATORIES, K94632818, 03/28/1995. Read More
ABBOTT LABORATORIES 相關藥物 | 合法醫療器材資訊網
ABBOTT LABORATORIES. 藥物廠商; ABBOTT LABORATORIES ... 亞培TDx/TDxFLx 古柯鹼代謝物檢驗試劑組 ... 亞培TDx/TDxFLx 苯二氮平類藥物檢驗試劑組 Read More
亞培TDxTDxFLx 尿液巴比妥類第二代檢驗試劑組 | 合法醫療器材資訊網
通關簽審文件編號, DHA00601234500. 中文品名, 亞培TDx/TDxFLx 尿液巴比妥類第二代檢驗試劑組. 英文品名, ABBOTT TDX/TDXFLX BARBITURATES IIU. 效能. Read More
亞培TDxTDxFLx 尿液巴比妥類第二代檢驗試劑組ABBOTT TDX ... | 合法醫療器材資訊網
亞培TDx/TDxFLx 尿液巴比妥類第二代檢驗試劑組ABBOTT TDX/TDXFLX BARBITURATES IIU / 螢光偏極免疫分析法半定量測試人類尿液樣本中的巴比妥類藥物之 ... Read More
藥品一覽 | 合法醫療器材資訊網
亞培TDx/TDxFLx 尿液巴比妥類第二代檢驗試劑組. ABBOTT TDX/TDXFLX BARBITURATES IIU ... 亞培" 胃造口管組 "Abbott" Flexiflo Gastrostomy tube ... Read More
醫療器材許可證資料集 | 合法醫療器材資訊網
... 亞培愛可信萬古黴素第二代檢驗試劑組, ABBOTT AXSYM VANCOMYCIN II ... ABBOTT TDX/TDXFLX BARBITURATES IIU, A 臨床化學及臨床毒理學用裝置, 輸入 ... Read More
相關資訊整理
【亞培 TDx/TDxFLx 尿液巴比妥類第二代檢驗試劑組】許可證字號:衛署醫器輸字第012345號
器材品名:亞培TDx/TDxFLx尿液巴比妥類第二代檢驗試劑組許可證字號:衛署醫器輸字第012345號註銷狀態:已註銷註銷日期:2012/11/...