• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt
510(k) Number K120563
Device Name KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
Original Applicant
MICROPHAGE, INC.
2400 trade centre ave
longmont,  CO  80503
Original Contact drew smith
Regulation Number866.2050
Classification Product Code
OUS  
Date Received02/24/2012
Decision Date 03/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-