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.
 
DeviceLeukoStrat® CDx FL T3 Mutation Assay
Generic NameSomatic gene mutation detection system
ApplicantInvivoscribe Technologies, Inc.
10222 Barnes Canyon Rd.
Bldg. 1
San Diego, CA 92121
PMA NumberP160040
Supplement NumberS012
Date Received11/14/2022
Decision Date02/06/2023
Product Code OWD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for replacing NEBuffer 3.1, containing bovine serum albumin, with NEBuffer r3.1, containing recombinant (non-bovine) albumin in the LeukoStrat® CDx FLT3 Mutation Assay kit configuration.
-
-