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 microbial nucleic acid storage and stabilization device
De Novo Number DEN170029
Device Name PrimeStore MTM
Requester
longhorn vaccines and diagnostics llc
2 bethesda metro center, suite 910
bethesda,  MD  20814
Contact jeff fischer
Regulation Number866.2950
Classification Product Code
QBD  
Date Received05/24/2017
Decision Date 03/19/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-