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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSPOT-LIGHT HER2 CISH KIT
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Generic Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
Applicant
INVITROGEN CORPORATION
3175 staley rd.
grand island, NY 14072
PMA NumberP050040
Supplement NumberS001
Date Received02/03/2011
Decision Date07/12/2011
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED IN FREDERICK, MARYLAND.
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