• 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 | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name trichomonas vaginalis nucleic acid amplification test system
510(k) Number K122062
Model 303537 AND 303536
Device Name APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
Original Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego,  CA  92121 4362
Original Contact maria carmelita s baluyot
Regulation Number866.3860
Classification Product Code
OUY  
Date Received07/13/2012
Decision Date 01/09/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-