• 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.
 
DevicePraxis Extended RAS Panel
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
Illumina, Inc.
5200 illumina way
san diego, CA 92122
PMA NumberP160038
Supplement NumberS017
Date Received08/04/2020
Decision Date09/02/2020
Product Code PQP 
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 
Implementation of two new quantitative quality control (QC) testing assays.
-
-