Modification To | 合法醫療器材資訊網
References
MRR
(fda.report)
21 CFR 862.1475
(ecfr.io)
summary
(fda.report)
Device ID
K012287
510k Number
K012287
Device Name:
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND
GENERATION
Classification
System, Test, Low Density, Lipoprotein
Applicant
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,
IN 46250 -0457
Contact
Sherri L Coenen
Correspondent
Sherri L Coenen
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,
IN 46...
COBAS INTEGRA LDL-Cholesterol plus 2nd generation COBAS INTEGRA LDL-Cholesterol plus 2nd generation Maquet getinge autoclave price steris autoclave preferred homecare lifecare solutions nebulizer 星辰手臂式電子血壓計chd701 星辰血壓計校正 COPAN 代理 SARSTEDT
on which cobas c pack(s) can be used 03038866 322 LDL ... | 合法醫療器材資訊網
Class 2 Device Recall Roche Diagnostics LDL | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
ROCHE DIAGNOSTICS OPERATIONS | 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
Modification To | 合法醫療器材資訊網
HDL | 合法醫療器材資訊網
Multiple Chemistry Assays by Roche Diagnostics (2015 | 合法醫療器材資訊網
Corrective action for COBAS INTEGRA 400400 plus ... | 合法醫療器材資訊網
相關資訊整理
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器材品名:可霸斯印諦快低密度膽固醇檢驗試劑第二代許可證字號:衛署醫器輸壹字第000784號註銷狀態:已註銷註銷日期:2013/01/18...