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 Susceptibility Test Plate, Antifungal
510(k) Number K090968
Device Name SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
Applicant
Trek Diagnostic Systems, Inc.
982 Keynote Circle, Suite 6
Cleveland,  OH  44131
Applicant Contact Cynthia Knapp
Correspondent
Trek Diagnostic Systems, Inc.
982 Keynote Circle, Suite 6
Cleveland,  OH  44131
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
NGZ  
Date Received04/06/2009
Decision Date 06/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-