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 G Kappa Heavy And Light Chain Combined
510(k) Number K132555
Device Name HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
Applicant
The Binding Site
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact Paul Kenny
Correspondent
The Binding Site
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact Paul Kenny
Regulation Number866.5510
Classification Product Code
PCN  
Subsequent Product Code
PCO  
Date Received08/14/2013
Decision Date 12/20/2013
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
-
-