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 fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus
510(K) Number K113371
Device Name STAPHYLOCOCCUS QUICKFISH BC
Applicant
ADVANDX, INC.
400 tradecenter
suite 6990
woburn,  MA  01801
Contact benjamin s crystal
Regulation Number866.3700
Classification Product Code
NXX  
Date Received11/17/2011
Decision Date 04/03/2012
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
-
-