• 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 setmelanotide eligibility gene variant detection system
De Novo Number DEN200059
Device Name POMC/PCSK1/LEPR CDx Panel
Requester
preventiongenetics, llc
3800 s. business park avenue
marshfield,  WI  54449
Contact jerry machado
Regulation Number862.1164
Classification Product Code
QRV  
Date Received09/18/2020
Decision Date 01/21/2022
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-