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510(k) K150031

hemoFISH Masterpanel by Miacom Diagnostics GmbH — Product Code JSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2015
Date Received
January 8, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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