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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name c. difficile nucleic acid amplification test assay
510(K) Number K113358
Device Name PORTRAIT ANALYZER
Applicant
GREAT BASIN SCIENTIFIC
2441 s. 3850 w.
west valley,  UT  84120
Contact larry rea
Regulation Number866.2660
Classification Product Code
OMN  
Subsequent Product Code
OZN  
Date Received11/14/2011
Decision Date 04/30/2012
Decision de novo petitions granted (AN)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-