510(k) Premarket Notification | 合法醫療器材資訊網
References
Products Classification
Database Information for Antinuclear Antibody
(Enzyme-Labeled), Antigen, Controls
(www.accessdata.fda.gov)
Code of Federal Regulations
(CFR) database information for 866.5100
(www.accessdata.fda.gov)
PDF for K083188
(www.accessdata.fda.gov)
pdf of 510(k) K083188
(www.accessdata.fda.gov)
Device Classification Name
antinuclear antibody
(enzyme-labeled), antigen, controls[1]
510(k) Number
K083188
Device Name
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
...
Varelisa ReCombi ANA Screen Varelisa ReCombi ANA Screen "奇維" 壓迫式動脈止血器 (未滅菌) 神經傳導檢查 後遺症 “Song Young” Dental Led Head Light (Non-Sterile) 美德耐氧化鋅繃帶(未滅菌) "LUT" Orthopedics Endoscopic Instruments (Non-Sterile) "巴德斯" 機械式助行器(未滅菌) Carin ENURESIS ALARM Sensor (Non-Sterile) 電子血壓計
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION | 合法醫療器材資訊網
Improved Serological Differentiation between ... | 合法醫療器材資訊網
Improved serological differentiation between ... | 合法醫療器材資訊網
K083188 VARELISA RECOMBI ANA SCREEN | 合法醫療器材資訊網
K993108.pdf | 合法醫療器材資訊網
REVIEW MEMORANDUM | 合法醫療器材資訊網
Screens - Phadia | 合法醫療器材資訊網
凡立沙基因重組抗核抗體篩檢試劑Varelisa ReCombi ANA Screen ... | 合法醫療器材資訊網
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