510(k) K131275

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS by Siemens Helathcare Diagnostics, Inc. — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2013
Date Received
May 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panels, Test, Susceptibility, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type