510(k) K000762

MOXIFLOXACIN, 5 UG, BBL SENSI-DISC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2000
Date Received
March 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type