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
510(k) Number K253653
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
Date Received11/20/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
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
-
-