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.
 
DeviceROCHE COBAS 4800 BRAF V600 MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP110020
Supplement NumberS001
Date Received09/19/2011
Decision Date10/17/2011
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
ADDITIONAL OF FUNCTIONAL TESTING AT THE FINAL VIAL STAGE IN THE MANUFACTURE OF THE DEVICE MUTATION POSITIVE CONTROL (MU) AND THE WILD-TYPE CONTROL (WT).
-
-