Premarket Approval for Abbott Molecular, Inc., Abbott RealTime HCV, Abbott RealTime HCV Amplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional UNG Uracil-M-Glycosylase (UNG) P100017, Approved 5/17/11

Docket ID: FDA-2011-M-0349
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Status: OPEN
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Keyword(s): P100017, Abbott Molecular, Inc., Abbott RealTime HCV, Abbott RealTime HCV , UNG Uracil-M-Glycosylase
Type: Nonrulemaking
Center: CDRH
Docket Item Code: M

Primary Documents

View All  (2)
Comment Period Closed
Posted: 08/04/2011
ID: FDA-2011-M-0349-0002
Comment Period Closed
Posted: 07/06/2011
ID: FDA-2011-M-0349-0001

Supporting Documents

No documents available.


No comments posted.

Comments Received*
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