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 Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
510(k) Number K213280
Device Name BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Applicant
BD Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Applicant Contact Karin Brands
Correspondent
BD Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Correspondent Contact Karin Brands
Regulation Number866.2190
Classification Product Code
QQY  
Date Received10/01/2021
Decision Date 05/04/2023
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
-
-