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 Immunoglobulin A Kappa Heavy & Light Chain Combined
510(k) Number K160819
Device Name Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Applicant Contact JON LAUDER
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Correspondent Contact JON LAUDER
Regulation Number866.5510
Classification Product Code
OPX  
Subsequent Product Code
OPY  
Date Received03/24/2016
Decision Date 06/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-