FDA 510(k) Application Details - K961188

Device Classification Name Susceptibility Test Discs, Antimicrobial

  More FDA Info for this Device
510(K) Number K961188
Device Name Susceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE, MD 21030-0243 US
Other 510(k) Applications for this Company
Contact VIRGINIA C WEINKNECHT
Other 510(k) Applications for this Contact
Regulation Number 866.1620

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

  More FDA Info for this Product Code
Date Received 03/26/1996
Decision Date 04/05/1996
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