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510(k) K072149

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 by Phadia US, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2008
Date Received
August 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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