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 albumin, antigen, antiserum, control
510(k) Number K121045
Device Name HUMAN ALBUMIN CSF KIT
Applicant
THE BINDING SITE GROUP, LTD.
8 CALTHORPE ROAD
EDGBASTON,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
THE BINDING SITE GROUP, LTD.
8 CALTHORPE ROAD
EDGBASTON,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5040
Classification Product Code
DCF  
Date Received04/06/2012
Decision Date 06/19/2013
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
-
-