• 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 | Inspections

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.
Classification Namechromogenic in situ hybridisation, nucleic acid amplification, her2/neu gene, breast cancer
PMA NumberP100024
Supplement NumberS007
Date Received08/13/2015
Decision Date09/10/2015
Product Code
NYQ[ Registered Establishments with NYQ ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Alternate warehouse established within the current facility. The change is being made for the storage of finished devices after they have been qa released.