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 | TOP2A FISH PHARMDX 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 | S003 |
Date Received | 10/06/2011 |
Decision Date | 11/10/2011 |
Product Code |
NXG
|
Advisory Committee |
Pathology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
ADD AN ALTERNATE SUPPLIER OF TEXAS RED LABELED DCTP NUCLEOTIDE AND TO REPLACE AN IN-PROCESS QC PROCEDURE WITH A NEW QC TEST ON FFPE BREAST CANCER TISSUE. |
|
|