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, Urea Nitrogen
510(k) Number K855091
Device Name CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
Applicant
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55126
Applicant Contact WALTER L SEMBROWICH
Correspondent
Sen Tech Medical Corp.
3771 Lexington Ave.
Arden Hills,  MN  55126
Correspondent Contact WALTER L SEMBROWICH
Regulation Number862.1770
Classification Product Code
CDS  
Date Received12/20/1985
Decision Date 03/14/1986
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
-
-