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 Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K101461
Device Name BD DIRECTIGEN EX FLU A+B
Applicant
Becton, Dickinson and Company
11085 N. Torrey Pines Rd.
Suite 210
La Jolla,  CA  92037
Applicant Contact GREGORY PAYNE
Correspondent
Becton, Dickinson and Company
11085 N. Torrey Pines Rd.
Suite 210
La Jolla,  CA  92037
Correspondent Contact GREGORY PAYNE
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received05/26/2010
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-