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510(k) K860996

SANASSAY IC TEST by Scientific Sales Intl., Inc. — Product Code DAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
March 11, 1986
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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  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
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