• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceTOP2A FISH PHARMDX KIT
Classification Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Generic Namefluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Applicant
DAKO DENMARK A/S
42 produktionsvej
2600 glostrup DK-26-2600
PMA NumberP050045
Supplement NumberS003
Date Received10/06/2011
Decision Date11/10/2011
Product Code
NXG[ Registered Establishments with NXG ]
Advisory Committee Pathology
Supplement Type30-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.
-
-