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 Multiplex Nucleic Acid Detection System For Biothreat Agents
510(k) Number K261362
Device Name Xpert Hemorrhagic Fever
Applicant
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Suzette Chance
Correspondent
Cepheid
904 Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Katy Reilly
Classification Product Code
QVR  
Subsequent Product Code
OOI  
Date Received04/27/2026
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Dual Track
Clinical Trials NCT07591740
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-