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 Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K160459
Device Name FilmArray Gastrointestinal Panel (GI) 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 Number866.3990
Classification Product Code
PCH  
Date Received02/19/2016
Decision Date 04/01/2016
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
Recalls CDRH Recalls
-
-