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

510(k) Premarket Notification
  • 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
Device Classification Name chronic lymphocytic leukemia fish probe kit
510(k) Number K100015
Device Name VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
des plaines,  IL  60018
Applicant Contact pamela l swatkowski
Correspondent
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
des plaines,  IL  60018
Correspondent Contact pamela l swatkowski
Regulation Number866.6040
Classification Product Code
OVQ  
Date Received01/04/2010
Decision Date 08/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-