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 Radioimmunoassay, Estradiol
510(k) Number K973901
Device Name 17 B-ESTRADIOL (ELISA)
Applicant
Kmi Diagnostics, Inc.
818 51st Ave., NE
Suite 101
Minneapolis,  MN  55421
Applicant Contact MARK A KOWAL
Correspondent
Kmi Diagnostics, Inc.
818 51st Ave., NE
Suite 101
Minneapolis,  MN  55421
Correspondent Contact MARK A KOWAL
Regulation Number862.1260
Classification Product Code
CHP  
Date Received10/14/1997
Decision Date 11/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-