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510(k) K140493

ELIA SCL-70S IMMUNOASSAY by Phadia GmbH — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2014
Date Received
February 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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