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 assay, nucleic acid amplification, bacillus anthracis
510(k) Number K051713
Device Name JBAIDS ANTHRAC DETECTION SYSTEM
Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Applicant Contact beth lingenfelter
Correspondent
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city,  UT  84108
Correspondent Contact beth lingenfelter
Regulation Number866.2660
Classification Product Code
NHT  
Date Received06/27/2005
Decision Date 11/18/2005
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
Expedited Review Yes
Combination Product No
-
-