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 K851808
Device Name ELECTROLYTE ANALYZER
Applicant
IONETICS, INC.
3020 ENTERPRISE
COSTA MESA,  CA  92626
Applicant Contact KATER
Correspondent
IONETICS, INC.
3020 ENTERPRISE
COSTA MESA,  CA  92626
Correspondent Contact KATER
Regulation Number862.1600
Classification Product Code
CEM  
Date Received04/15/1985
Decision Date 06/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-