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 Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
510(k) Number K131936
Device Name JBAIDS TULAREMIA DETECTION KIT
Applicant
Biofire Diagnostics, Inc.
390 Wakara Way
Salt Lake City,  UT  84108
Applicant Contact CYNTHIA PHILIPS
Correspondent
Biofire Diagnostics, Inc.
390 Wakara Way
Salt Lake City,  UT  84108
Correspondent Contact CYNTHIA PHILIPS
Regulation Number866.3280
Classification Product Code
OEH  
Date Received06/27/2013
Decision Date 07/31/2013
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
Predetermined Change
Control Plan Authorized		 No
-
-