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510(k) K011662

MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL by The Binding Site, Ltd. — Product Code DDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2001
Date Received
May 29, 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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