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 K970330
Device Name DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
Applicant
DADE INTL., INC.
BUILDING 500, MAILBOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact CAROLYN K GEORGE
Correspondent
DADE INTL., INC.
BUILDING 500, MAILBOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JFL   JGS  
Date Received01/28/1997
Decision Date 04/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-