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, enterococcus faecalis
510(K) Number K063127
Device Name ENTEROCOCCUS FAECALIS PNA FISH
Applicant
ADVANDX, INC.
690 canton street, suite 302
westwood,  MA  02090
Contact amy aulwes
Regulation Number866.3740
Classification Product Code
OAH  
Date Received10/16/2006
Decision Date 12/22/2006
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
-
-