|
Device | TOP2A FISH PHARMADX KIT |
Generic Name | Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion |
Applicant | DAKO DENMARK A/S 42 PRODUKTIONSVEJ 2600 GLOSTRUP DK-26-2600 |
PMA Number | P050045 |
Supplement Number | S004 |
Date Received | 12/23/2011 |
Decision Date | 06/01/2012 |
Withdrawal Date
|
01/24/2018 |
Product Code |
NXG |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE. |