• 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.
 
DeviceVysis CLL Fish Probe Kit
Generic Namefluorescence in situ hybridization, chromosome 17p deletion (tp53)
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP150041
Supplement NumberS001
Date Received11/08/2017
Decision Date12/06/2017
Product Code PNK 
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 
Vendors relocation of a manufacturing site for production of reagents contained in kit components.
-
-