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510(k) K133404

IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH by Phadia AB — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2014
Date Received
November 6, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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