510(k) K111394

MICROSCAN MICROSTEP by Siemens Healthcare Diagnostics, Inc. — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2011
Date Received
May 18, 2011
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