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 electrode, ion specific, potassium
510(k) Number K110520
Device Name BIOLIS 12I
Applicant
TOKYO BOEKI MEDISYS INC.
5105 FAIROAKS ROAD
DURHAM,  NC  27712
Applicant Contact James M Clinton
Correspondent
TOKYO BOEKI MEDISYS INC.
5105 FAIROAKS ROAD
DURHAM,  NC  27712
Correspondent Contact James M Clinton
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   CGZ   JGS   JJE  
Date Received02/23/2011
Decision Date 03/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-