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 respiratory virus panel nucleic acid assay system
510(k) Number K171552
Device Name Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089 -1189
Applicant Contact Yi-Ping Lin
Correspondent
Cepheid
904 Caribbean Drive
Sunnyvale,  CA  94089 -1189
Correspondent Contact Jim Kelly
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
JSM   OOI  
Date Received05/26/2017
Decision Date 12/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
-
-