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510(k) K981783

C3 MININEPH ANTISERUM by The Binding Site, Ltd. — Product Code CZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1999
Date Received
May 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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