• 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 K071188
Device Name MODIFICATION TO JBAIDS ANTHRAX 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 Number866.3045
Classification Product Code
NHT  
Date Received04/30/2007
Decision Date 05/21/2007
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
-
-