• 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 respiratory virus panel nucleic acid assay system
510(k) Number K160068
FOIA Releasable 510(k) K160068
Device Name FilmArray Respiratory Panel (RP) for use with FilmArray Torch
Applicant
BioFire Diagnostics, LLC
390 Wakara Way
salt lake city,  UT  84108
Applicant Contact kristen j. kanack
Correspondent
BioFire Diagnostics, LLC
390 Wakara Way
salt lake city,  UT  84108
Correspondent Contact kristen j. kanack
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP   OOU   OTG   OZX  
OZZ  
Date Received01/13/2016
Decision Date 02/08/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-