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 system, test, automated, antimicrobial susceptibility, short incubation
510(k) Number K050982
Device Name BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact MONICA E GIGUERE
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact MONICA E GIGUERE
Regulation Number866.1645
Classification Product Code
LON  
Date Received04/19/2005
Decision Date 05/24/2005
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
-
-