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 K112995
Device Name GEM PREMIER 4000
Applicant
INSTRUMENTATION LABORATORY CO.
526 ROUTE 303
ORANGEBURG,  NY  10962
Applicant Contact CARL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
526 ROUTE 303
ORANGEBURG,  NY  10962
Correspondent Contact CARL MARBLE
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGA   CGZ   CHL   CIG   GHS  
GKF   GKR   GLK   GLY   JFP   JGS  
JJY   KHP   MQM  
Date Received10/07/2011
Decision Date 05/03/2012
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
-
-