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510(k) K053533

IMMULITE/IMMULITE 1000 TURBO INTACT PTH by Diagnostic Products Corporation — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2006
Date Received
December 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

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