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 Device, Specimen Collection
510(k) Number K890134
Device Name FTK FECAL TRANSPORT KIT
Applicant
Evergreen Scientific, Inc.
2300 E. 49th St.
P.O. Box 58248
Los Angeles,  CA  90058
Applicant Contact WONG
Correspondent
Evergreen Scientific, Inc.
2300 E. 49th St.
P.O. Box 58248
Los Angeles,  CA  90058
Correspondent Contact WONG
Regulation Number866.2900
Classification Product Code
LIO  
Date Received01/13/1989
Decision Date 04/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-