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 Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K250358
Device Name BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Applicant Contact Joseph Basore
Correspondent
Becton, Dickinson and Company
7 Loveton Circle
Sparks,  MD  21152
Correspondent Contact Joseph Basore
Regulation Number866.3990
Classification Product Code
PCI  
Subsequent Product Codes
OOI   PCH  
Date Received02/07/2025
Decision Date 10/31/2025
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
Predetermined Change
Control Plan Authorized		 No
-
-