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510(k) K841541

SERUM COMPLEMENT ACTIVITY TEST-SCAT by Collaborative Research, Inc. — Product Code DAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
April 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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