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


New Search Back To Search Results
Device Classification Name c. difficile nucleic acid amplification test assay
510(k) Number DEN120013
Device Name PORTRAIT ANALYZER
Original Applicant
GREAT BASIN SCIENTIFIC
2441 s. 3850 w.
west valley,  UT  84120
Original Contact larry rea
Regulation Number866.2660
Classification Product Code
OMN  
Date Received03/02/2012
Decision Date 04/30/2012
Decision an (AN)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Post-NSE
Reviewed by Third Party No
Combination Product No
-
-