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 Test, Cystatin C
510(k) Number K072166
Device Name CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
Applicant
THE BINDING SITE
2425 WEST OLYMPIC BOULEVARD
WEST TOWER SUITE 4000
SANTA MONICA,  CA  90404
Applicant Contact JAY GELLER
Correspondent
THE BINDING SITE
2425 WEST OLYMPIC BOULEVARD
WEST TOWER SUITE 4000
SANTA MONICA,  CA  90404
Correspondent Contact JAY GELLER
Regulation Number862.1225
Classification Product Code
NDY  
Date Received08/06/2007
Decision Date 01/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-