• 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 dna-reagents, neisseria
510(k) Number K081825
Device Name BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
Original Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152 0999
Original Contact kathryn b carr
Regulation Number866.3390
Classification Product Code
LSL  
Date Received06/27/2008
Decision Date 12/11/2008
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-