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 System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
510(k) Number K130775
Device Name DUET SYSTEM
Applicant
BIOVIEW LTD.
25A SIRKIN ST.
KFAR SABA,  IL 44421
Applicant Contact ORLY MAOR
Correspondent
BIOVIEW LTD.
25A SIRKIN ST.
KFAR SABA,  IL 44421
Correspondent Contact ORLY MAOR
Regulation Number866.4700
Classification Product Code
NTH  
Subsequent Product Code
JOY  
Date Received03/20/2013
Decision Date 05/09/2014
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
-
-