Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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.
 
DeviceOncomine Dx Express Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLife Technologies Corporation
7335 Executive Way
Frederick, MD 21704
PMA NumberP240040
Supplement NumberS002
Date Received08/01/2025
Decision Date10/15/2025
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the non-clinical Post-Approval Study (PAS) protocol for precision and sample equivalency studies using core needle biopsy and fine needle aspirate samples (PCP0141593).
-
-