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 system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen
510(k) Number K173263
Device Name Xpert Carba-R
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 Number866.1640
Classification Product Code
POC  
Subsequent Product Codes
OOI   PMY  
Date Received10/11/2017
Decision Date 01/09/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-