• 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 fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus
510(k) Number K092166
Model KT005
Device Name S. AUREUS/CNS PNA FISH, MODEL KT005
Original Applicant
ADVANDX, INC.
10a roessler road
woburn,  MA  01801
Original Contact paula e bulger
Regulation Number866.3700
Classification Product Code
NXX  
Date Received07/21/2009
Decision Date 11/23/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-