• 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, enterococcus faecalis
510(k) Number K082612
Device Name GBS PNA FISH
Original Applicant
10a roessler road
woburn,  MA  01801
Original Contact paula e bulger
Regulation Number866.3740
Classification Product Code
Date Received09/09/2008
Decision Date 05/05/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No