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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 early growth response gene 1 (egr1) fish probe kit for specimen characterization
De Novo Number DEN130010
510(K) Number K123951
Device Name VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Requester
abbott molecular, inc.
1300 east touhy avenue
des plaines,  IL  60018
Contact nancy w bengtson
Regulation Number864.1870
Classification Product Code
PDO  
Date Received04/09/2013
Decision Date 07/29/2013
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
-
-