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” GSP Neonatal Biotinidase Kit “WALLAC OY” GSP Neonatal Biotinidase Kit Asahi CT MX 60N 百特組織修復凝合劑價格 微創手術保險理賠 麻醉機原理 動物用氣體麻醉機 三重 聯合醫院-住院費用 FABERSANITAS" DISPOSABLE
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
88918 GSP Brochure change | 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
GSP newborn screening system brochure | 合法醫療器材資訊網
K131284 GSP NEONATAL BIOTINIDASE KIT | 合法醫療器材資訊網
SCREENING | 合法醫療器材資訊網
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