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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 K092166
Device Name S. AUREUS/CNS PNA FISH, MODEL KT005
Applicant
ADVANDX, INC.
10A ROESSLER ROAD
WOBURN,  MA  01801
Applicant Contact PAULA E BULGER
Correspondent
ADVANDX, INC.
10A ROESSLER ROAD
WOBURN,  MA  01801
Correspondent Contact PAULA E BULGER
Regulation Number866.3700
Classification Product Code
NXX  
Date Received07/21/2009
Decision Date 11/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-