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 Based, Enzymatic, Creatinine
510(k) Number K903034
Device Name RENALYZER PRX 90
Applicant
Swedish Trade Council USA
150 N. Michigan Ave.
Suite 1200
Chicago,  IL  60601
Applicant Contact ANDERS SJOBERG
Correspondent
Swedish Trade Council USA
150 N. Michigan Ave.
Suite 1200
Chicago,  IL  60601
Correspondent Contact ANDERS SJOBERG
Regulation Number862.1225
Classification Product Code
CGL  
Date Received07/11/1990
Decision Date 03/13/1991
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
-
-