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 Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
510(k) Number K140465
Device Name VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
Applicant
Ventana Medical Systems, Inc.
203 Ravendale Dr.
Mountain View,  CA  94043
Applicant Contact MORT MINAEE
Correspondent
Ventana Medical Systems, Inc.
203 Ravendale Dr.
Mountain View,  CA  94043
Correspondent Contact MORT MINAEE
Regulation Number864.1860
Classification Product Code
NQN  
Subsequent Product Codes
NOT   OEO  
Date Received02/24/2014
Decision Date 03/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-