Ventana Medical Systems, Inc., Premarket Approval for INFORM® HER2 Dual ISH DNA Probe Cocktail P100027, Approved 6/14/11

Docket ID: FDA-2011-M-0472
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): P100027, PMA, Dual ISH DNA Probe Cocktail , INFORM® HER2 , Ventana Medical Systems, Inc., CDRH
Type: Nonrulemaking
Center: CDRH
Docket Item Code: M

Primary Documents

View All  (2)
Comment Period Closed
Posted: 08/17/2011
ID: FDA-2011-M-0472-0002
Comment Period Closed
Posted: 08/04/2011
ID: FDA-2011-M-0472-0001

Supporting Documents

No documents available.


No comments posted.

Comments Received*
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