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 K230651
Device Name BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
Applicant
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Applicant Contact Katherine Cicala
Correspondent
Becton, Dickinson and Company
7loveton Cir.
Sparks,  MD  21152
Correspondent Contact Katherine Cicala
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/09/2023
Decision Date 06/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-