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, Sodium
510(k) Number K932179
Device Name MODEL 400/450 ELECTROLYTE ANALYZER
Applicant
Ionetics, Inc.
3020 Enterprise
Costa Mesa,  CA  92626
Applicant Contact JOHN KATER
Correspondent
Ionetics, Inc.
3020 Enterprise
Costa Mesa,  CA  92626
Correspondent Contact JOHN KATER
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Code
CGZ  
Date Received05/05/1993
Decision Date 11/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-