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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 trichomonas vaginalis nucleic acid amplification test system
De Novo Number DEN110012
510(K) Number K102911
Device Name APTIMA TRICHOMONAS VAGINALIS ASSAY
Requester
gen-probe incorporated
10210 genetic center dr.
san diedgo,  CA  92121
Contact maria carmelita s baluyot
Regulation Number866.3860
Classification Product Code
OUY  
Date Received04/13/2011
Decision Date 04/19/2011
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
-
-