• 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 lower respiratory microbial nucleic acid detection system
510(k) Number K180966
Device Name FilmArray Pneumonia Panel
Applicant
BioFire Diagnostics, LLC
515 Colorow Drive
salt lake city,  UT  84108
Applicant Contact kristen j. kanack
Correspondent
BioFire Diagnostics, LLC
515 Colorow Drive
salt lake city,  UT  84108
Correspondent Contact kristen j. kanack
Regulation Number866.3985
Classification Product Code
QBH  
Date Received04/13/2018
Decision Date 11/09/2018
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
-
-