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 K843008
Device Name ION SELECTIVE ELECTRODES & REAGENT SYS
Applicant
American Monitor Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Monitor Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1600
Classification Product Code
CEM  
Date Received07/31/1984
Decision Date 09/04/1984
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
-
-