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510(k) K120236

TRANSFERRIN KIT FOR USE ON THE SPAPLUS by The Binding Site Group , Ltd. — Product Code DDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2013
Date Received
January 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
Submission Type

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