Premarket Approval for Ortho-Clinical Diagnostics, Inc., VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls P090028, Approved 5/11/11

Docket ID: FDA-2011-M-0348
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): cdrh, Ortho-Clinical Diagnostics, Inc., VITROS® , Immunodiagnostic Products HBeAg Reagent , P090028
Type: Nonrulemaking
Center: CDRH
Docket Item Code: M

Primary Documents

View All  (2)
Comment Period Closed
Posted: 08/04/2011
ID: FDA-2011-M-0348-0002
Comment Period Closed
Posted: 06/21/2011
ID: FDA-2011-M-0348-0001

Supporting Documents

No documents available.


No comments posted.

Comments Received*
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