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 K810135
Device Name MODEL AM 721 ELECTROLYTE ANALYZER
Applicant
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Correspondent
Abbott Diagnostics
850 Maude Ave.
Mountain View,  CA  94043
Regulation Number862.1665
Classification Product Code
JGS  
Date Received01/21/1981
Decision Date 02/10/1981
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
-
-