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 Manual Antimicrobial Susceptibility Test Systems
510(k) Number K243169
Device Name The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
Applicant
Thermo Fisher Scientific
1 Thermofisher Way
Oakwood Village,  OH  44146
Applicant Contact Joel Mathew
Correspondent
Thermo Fisher Scientific
1 Thermofisher Way
Oakwood Village,  OH  44146
Correspondent Contact Dylan Staats
Regulation Number866.1640
Classification Product Code
JWY  
Subsequent Product Codes
LRG   LTT  
Date Received09/30/2024
Decision Date 12/19/2024
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
Predetermined Change
Control Plan Authorized		 No
-
-