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510(k) K012393

TINA-QUANT TRANSFERRIN VER.2 by Roche Diagnostics Corp. — Product Code DDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2001
Date Received
July 27, 2001
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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