510(k) Premarket Notification | 合法醫療器材資訊網
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.
Learn more...[1]
References Learn more... (www.fda.gov)
Wallac Oy Neonatal Biotinidase Kit Wallac Oy Neonatal Biotinidase Kit 長照設備補助 久立藥品有限公司 大昌華嘉產品 台灣大昌華嘉股份有限公司統一編號 a&d medical血壓計 and blood pressure monitor ua-767 觀達手套 “KaVo” Orthopantomograph OP
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
Decision Summary | 合法醫療器材資訊網
Gsp Neonatal Biotinidase Kit 510(k) FDA Premarket ... | 合法醫療器材資訊網
k131284 B. Purpose for Sub | 合法醫療器材資訊網
Neonatal Biotinidase kit | 合法醫療器材資訊網
豐技生物素酵素缺乏症篩檢試劑Wallac Oy Neonatal Biotinidase Kit ... | 合法醫療器材資訊網
相關資訊整理
【豐技生物素酵素缺乏症篩檢試劑】許可證字號:衛署醫器輸字第020852號
器材品名:豐技生物素酵素缺乏症篩檢試劑許可證字號:衛署醫器輸字第020852號註銷狀態:註銷日期:註銷理由:有效日期:2025/03/15...