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 susceptibility test discs, antimicrobial
510(k) Number K170127
Device Name HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
Applicant
Hardy Diagnostics
1430 West McCoy Lane
Santa Maria,  CA  93455
Applicant Contact Rianna Malherbe
Correspondent
Hardy Diagnostics
1430 West McCoy Lane
Santa Maria,  CA  93455
Correspondent Contact Rianna Malherbe
Regulation Number866.1620
Classification Product Code
JTN  
Date Received01/13/2017
Decision Date 03/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-