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 |
Withdrawal Date
|
01/07/2015 |
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. |
|
|