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510(k) K992488

TOTAL HAEMOLYTIC COMPLEMENT RID KIT by The Binding Site, Ltd. — Product Code DAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
July 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C9, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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