• 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 groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K173398
Device Name Xpert Xpress Strep A
Applicant
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Applicant Contact yi-ping lin
Correspondent
Cepheid
904 Caribbean Drive
sunnyvale,  CA  94089
Correspondent Contact jim kelly
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received10/31/2017
Decision Date 04/26/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
CLIA Waiver CLIA Waiver Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
-
-