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510(k) K951639

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) by Incstar Corp. — Product Code DAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1995
Date Received
April 10, 1995
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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