• 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.
 
DeviceTHERASCREEN EGFR RGQ PCR KIT
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
QIAGEN MANCHESTER LTD
skelton house
lloyd street north
manchester M15 6
PMA NumberP120022
Supplement NumberS014
Date Received12/28/2016
Decision Date05/19/2017
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Clinical Trials NCT00949650
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the Instructions for Use.
-
-