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
7 Loveton Circle
Sparks,  MD  21152 -0999
Applicant Contact Katherine Cicala
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152 -0999
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
-
-