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. |
|
Device | SPOT-LIGHT HER2 CISH KIT |
Generic Name | chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer |
Applicant |
INVITROGEN CORPORATION |
3175 staley rd. |
grand island, NY 14072 |
|
PMA Number | P050040 |
Supplement Number | S001 |
Date Received | 02/03/2011 |
Decision Date | 07/12/2011 |
Product Code |
NYQ
|
Advisory Committee |
Pathology |
Supplement Type | normal 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. |
|
|