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510(k) K100103

SPECIALTY ASSAYED CONTROL-2 by Helena Laboratories — Product Code GGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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