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 Antigens, All Groups, Streptococcus Spp.
510(k) Number K122718
Device Name BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
Applicant
Becton, Dickinson and Company
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Applicant Contact Gregory P Payne
Correspondent
Becton, Dickinson and Company
10865 Rd. To The Cure,
Suite 200
San Diego,  CA  92121
Correspondent Contact Gregory P Payne
Regulation Number866.3740
Classification Product Code
GTY  
Date Received09/05/2012
Decision Date 02/06/2013
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
-
-