FDA 510(k) Application Details - K041572

Device Classification Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

  More FDA Info for this Device
510(K) Number K041572
Device Name System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BECTON, DICKINSON AND CO.
7 LOVETON CIRCLE
SPARKS, MD US
Other 510(k) Applications for this Company
Contact MONICA E GIGUERE
Other 510(k) Applications for this Contact
Regulation Number 866.1645

  More FDA Info for this Regulation Number
Classification Product Code LON
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/14/2004
Decision Date 08/12/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact