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 Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K071100
Device Name AMNISCREEN HOME DETECTION LINER KIT
Applicant
Common Sense , Ltd.
1717 Rhode Island Ave., NW
Washington,  DC  20036
Applicant Contact NATASHA LESKOVSEK
Correspondent
Common Sense , Ltd.
1717 Rhode Island Ave., NW
Washington,  DC  20036
Correspondent Contact NATASHA LESKOVSEK
Regulation Number862.1550
Classification Product Code
CEN  
Date Received04/19/2007
Decision Date 10/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-