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 anti-müllerian hormone test system
De Novo Number DEN150057
Device Name Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
Requester
roche diagnostics
9115 hague rd.
indianapolos,  IN  46250
Contact edie eads
Regulation Number862.1092
Classification Product Code
PQO  
Date Received12/09/2015
Decision Date 12/19/2016
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-